Screwdriver, Skullplate
Neurology · 21 CFR 882.4900
Recent MDR events
16 adverse event reports on file
- HAND PIECE FOR BATTERY POWERED DRIVERAug 15, 2023MalfunctionSynthes Gmbh8030965-2023-10314
- HAND PIECE FOR BATTERY POWERED DRIVERAug 15, 2023MalfunctionSynthes Gmbh8030965-2023-10327
- HAND PIECE FOR BATTERY POWERED DRIVERAug 11, 2023MalfunctionSynthes Gmbh8030965-2023-10141
- HAND PIECE FOR BATTERY POWERED DRIVERJul 6, 2023MalfunctionSynthes Gmbh8030965-2023-08404
- HAND PIECE FOR BATTERY POWERED DRIVERJun 13, 2023MalfunctionSynthes Gmbh8030965-2023-07354
- HAND PIECE FOR BATTERY POWERED DRIVERMar 8, 2023MalfunctionSynthes Gmbh8030965-2023-02856
- HAND PIECE FOR BATTERY POWERED DRIVERMar 8, 2023MalfunctionSynthes Gmbh8030965-2023-02872
- HAND PIECE FOR BATTERY POWERED DRIVERMar 3, 2023MalfunctionSynthes Gmbh8030965-2023-02654
- HAND PIECE FOR BATTERY POWERED DRIVERJan 5, 2023MalfunctionWrights Lane Synthes Usa Products Llc2939274-2023-00001
- HAND PIECE FOR BATTERY POWERED DRIVERDec 22, 2022MalfunctionSynthes Gmbh8030965-2022-11441
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Synthes, Inc.TerminatedApr 14, 2014
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial b
The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. Therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label.
Z-1456-2014 · View FDA record ↗ - Medtronic NeurosurgeryTerminatedMay 6, 2006
Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215
Medtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhiibt burrs along the tips of the Screwdriver, which may prevent adequate engagement with the associated screws.
Z-0849-06 · View FDA record ↗
Registered firms
17 firms currently registered for this product code
Synthes Gmbh
Zuchwil Solothurn, CH
Pro-dex, Inc.
Irvine, CA, US
Biomet Microfixation
Jacksonville, FL, US
Gesco Healthcare Private Limited
CHENNAI, Tamil Nadu, IN
Depuy Synthes Sales
Bridgewater, MA, US
Shanghai Medical Instruments (group) Ltd. Corp.
Shanghai, CN
Sterigenics U.s., Llc
Corona, CA, US
Brainlab Se
Munich Bavaria, DE
Osteonic Co., Ltd.
Seoul, KR
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Synthes (usa) Products Llc
West Chester, PA, US
Dhf Praezisionsmechanik Gmbh
Tuntenhausen Bavaria, DE
Isomedix Operations, Inc
ONTARIO, CA, US
Jeil Medical Corporation
Seoul, KR
Pro-dex Inc
Tustin, CA, US
Kls Martin Se & Co. Kg
Muhlheim/Donau Baden-Wurttemberg, DE
Kontour (xi'an) Medical Technology Co., Ltd.
Xi'an Shaanxi, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.