FDA Adverse Event
Injury
Summary report: N
4.5MM LOCKING CONDYLAR PLATE
MDR report key: 1011889
·
Received March 11, 2008
Report
- Report Number
- 2520274-2008-00016
- Event Type
- Injury
- Date Received
- March 11, 2008
- Report Date
- February 14, 2008
- Manufacturer
- SYNTHES (USA)
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE THE MFR SITE OR THE MFR DATE WITHOUT A LOT #. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
A 4.5MM LOCKING CONDYLAR PLATE, IMPLANTED ON AN UNK DATE, BROKE POST-OPERATIVE. PT WAS DIAGNOSED WITH NONUNION. DURING A REVISION PROCEDURE, THE BROKEN HARDWARE WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.5MM LOCKING CONDYLAR PLATE | LOCKING CONDYLAR PLATES | HRS | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | SCREWS |