Drills, Burrs, Trephines & Accessories (manual)
Neurology · 21 CFR 882.4300
Recent MDR events
59 adverse event reports on file
- DISPOSABLE DRILL KITJun 9, 2026MalfunctionAd-tech Medical Instrument Corporation25443126
- TAP F/CORTSCR Ø4.5 L125/70Oct 15, 2025MalfunctionSynthes Gmbh8030965-2025-10433
- TAP F/RESORB CORT SCRWS Ø2 SELF-DRILL LJun 19, 2025MalfunctionSynthes Gmbh8030965-2025-06131
- CD HORIZON® SOLERA® SPINAL SYSTEMNov 6, 2024MalfunctionMedtronic Sofamor Danek Usa, Inc1030489-2024-01435
- CLEARPOINT NEUROAug 29, 2024InjuryClearpoint Neuro3028006458-2024-00003
- HAND DRILL - STERILEAug 21, 2024MalfunctionIntegra Pain Management1722447-2024-00007
- RUSKIN RONG 7-1/4 STR 5MMJun 27, 2024MalfunctionIntegra Lifesciences Mansfield3014334038-2024-00137
- HAND DRILL - STERILEMar 8, 2024MalfunctionIntegra Pain Management1722447-2024-00005
- HAND DRILL - STERILEMar 8, 2024MalfunctionIntegra Pain Management1722447-2024-00006
- HAND DRILL - STERILEFeb 22, 2024InjuryIntegra Pain Management1722447-2024-00004
Event type breakdown
Recalls
54 recall events for this product code
- Medtronic NeurosurgeryOpen, ClassifiedJul 21, 2026
Ventriculostomy Kit, REF: 46154
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.
Z-2768-2026 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedMay 20, 2024
Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure.
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Z-1873-2024 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedFeb 28, 2024
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Z-1193-2024 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedFeb 28, 2024
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Z-1194-2024 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedFeb 28, 2024
Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Z-1195-2024 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedFeb 28, 2024
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Z-1196-2024 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedFeb 28, 2024
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Z-1197-2024 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedFeb 28, 2024
Ref No: INS7260 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Z-1198-2024 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedFeb 28, 2024
Ref No: INS7270 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Z-1199-2024 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedFeb 28, 2024
INS7280 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Z-1200-2024 · View FDA record ↗
Registered firms
76 firms currently registered for this product code
Integra Lifesciences Production Corporation
Mansfield, MA, US
Integra Canada Ulc
Oakville Ontario, CA
Endoplus
Mundelein, IL, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Jarit Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Rudolf Storz Gmbh
EMMINGEN Baden-Wurttemberg, DE
Medtronic Neurosurgery
Fort Worth, TX, US
Phasor Health, Llc
Houston, TX, US
Sitec (pvt.) Ltd.
SIALKOT Punjab, PK
Teleflex Medical Llc
Morrisville, NC, US
Cbr Enterprise Limited
Hong Kong, HK
Qsa Surgical (pvt) Ltd.
SIALKOT Punjab, PK
Onyx Medical Llc
MEMPHIS, TN, US
Life Science Outsourcing, Inc.
Brea, CA, US
Clearpoint Neuro Inc.
Carlsbad, CA, US
Synthes (usa) Products Llc
West Chester, PA, US
Hemedex Incorporated
North Waltham, MA, US
Sterigenics Us Llc
Los Angeles, CA, US
Bashir Jamil & Brothers (pvt.), Ltd.
Sialkot Punjab, PK
Integra Lifesciences Corporation
Princeton, NJ, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Geomed Medizin-technik Gmbh & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Hipp Medical Ag
Renquishausen Baden-Wurttemberg, DE
510(k) clearances
17 clearances for this product code
- Phasor Health, LLCNov 21, 2025
K252696 · LEGACY
- Synthes (USA) Products, LLCJan 18, 2017
K153587 · Taps for Resorbable Screws
- Spineguard S.A.Jan 12, 2017
K162884 · SpineGuard DSG Zavation Screw System
- Mri Interventions, Inc.Mar 26, 2016
K160129 · MRII Cranial Drill and Accessories
- Mri Interventions, Inc.Jul 8, 2015
K151536 · SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
- Mri Interventions, Inc.Mar 22, 2013
K122456 · MRII CRAINIAL DRILL
- Medical Design, LLCNov 12, 2002
K022712 · HAND DRILL, MODEL 11-9901-7
- Medtronic Xomed, Inc.Oct 18, 2002
K022370 · FRAMELOCK; FRAMELOCK ACCESSORIES