FDA Adverse Event
Injury
Summary report: N
CONE-SHAPED SCREW FOR NUMELOCK PLATE
MDR report key: 1150513
·
Received September 4, 2008
Report
- Report Number
- 8031020-2008-00074
- Event Type
- Injury
- Date Received
- September 4, 2008
- Date of Event
- June 28, 2008
- Report Date
- August 11, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HWC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE IMPLANT SURGEON, REPORTED THAT THE PATIENT NOTICED THAT THERE WAS A PROTRUSION AT THE LEVEL OF THE OPERATIVE SCAR. THE SURGEON REPORTED THAT THIS PROTRUSION IS DUE TO A PART OF THE SCREW WHICH HAS BEEN EXPULSED. THE SURGEON REMOVED THE BROKEN PART OF THE SCREW. ALMOST 3/4 OF THE SCREW STAYED IN THE TIBIAL EPIPHYSIS. THE SURGEON INDICATED THAT, DUE TO THIS FACT, IT CAN BE DIFFICULT TO REMOVE THE PLATE. THE PLATE WAS IMPLANTED IN 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONE-SHAPED SCREW FOR NUMELOCK PLATE | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS SELZACH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |