Prosthesis, Condyle, Mandibular, Temporary
Dental · 21 CFR 872.4770
Recent MDR events
24 adverse event reports on file
- TITANIUM CONDYLAR HEADJun 21, 2024MalfunctionSynthes Gmbh8030965-2024-07785
- TI FIXATION PLATE F/CONDYLAR HEAD/0MMJun 21, 2024MalfunctionSynthes Gmbh8030965-2024-07786
- TITANIUM CONDYLAR HEADAug 12, 2021Malfunction8030965-2021-06602
- TI FIXATION PLATE F/CONDYLAR HEAD/0MMAug 12, 2021Malfunction8030965-2021-06603
- SLOTTED SCREW F/CONDYLAR HEAD ADD-ON SYS F/MATRIXMANDIBLEAug 12, 2021Malfunction8030965-2021-06604
- SLOTTED SCREW F/CONDYLAR HEAD ADD-ON SYS F/MATRIXMANDIBLEAug 12, 2021Malfunction8030965-2021-06605
- SLOTTED SCREW F/CONDYLAR HEAD ADD-ON SYS F/MATRIXMANDIBLEAug 12, 2021Malfunction8030965-2021-06606
- UNK MANDIBLE COMPONENTFeb 22, 2021Injury0001032347-2021-00077
- UNK CONDYLEFeb 11, 2021Injury0001032347-2021-00065
- SLOTTED SCREW F/CONDYLAR HEAD ADD-ON SYS F/MATRIXMANDIBLEJan 5, 2021Malfunction8030965-2021-00049
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
27 firms currently registered for this product code
Synthes Gmbh
Zuchwil Solothurn, CH
Kls-martin L.p.
Jacksonville, FL, US
Synthes (usa) Products Llc
West Chester, PA, US
Depuy Synthes Sales
Bridgewater, MA, US
Jabil Switzerland Manufacturing Gmbh (mezzovico)
Mezzovico Ticino, CH
Stryker Leibinger Gmbh & Co. Kg
FREIBURG Baden-Wurttemberg, DE
Osteomed
ADDISON, TX, US
Synthes Gmbh
Selzach Solothurn, CH
Exel Inc. Dba Dhl Supply Chain (usa)
Mooresville, IN, US
Kls Martin Se & Co. Kg
Muhlheim/Donau Baden-Wurttemberg, DE
Biomet, Inc.
WARSAW, IN, US
Biomet Microfixation
Jacksonville, FL, US
Jabil Inc. (elmira)
Horseheads, NY, US
Jabil Inc. (monument)
Monument, CO, US
Autocam Medical
Murfreesboro, TN, US
510(k) clearances
7 clearances for this product code
- StrykerApr 9, 2014
K133285 · STRYKER TEMPORARY CONDYLAR PROSTHESIS
- Synthes (Usa)Sep 5, 2008
K081747 · MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
- Synthes (Usa)Jan 5, 2007
K063181 · SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
- Osteomed LPJul 8, 2004
K031701 · OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
- Walter Lorenz Surgical, Inc.Aug 6, 2001
K002790 · ADD-ON CONDYLE
- KLS-Martin L.P.Jul 27, 2001
K990667 · KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
- Synthes (Usa)Oct 22, 1999
K990637 · SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD