FDA Adverse Event
Malfunction
Summary report: N
3.5MM VA-LCP PROX TIBIA PLATE LARGE BEND/12H/207MM/RT-STER
MDR report key: 2901046
·
Received January 8, 2013
Report
- Report Number
- 8030965-2013-00069
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Report Date
- December 11, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- HRS
- PMA / PMN Number
- K120689
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
Additional Manufacturer Narrative · 1
A MANUFACTURING EVALUATION WAS CONDUCTED. IT IS NOTED THAT THE OUTER PLASTIC SEAL IS DAMAGED; THE CARDBOARD BOX SHOWS A SLIGHT SCRATCHING MARK. IT IS UNKNOWN WHEN AND WHERE IN TRANSIT THE DAMAGE HAPPENED. A CONCLUSION CANNOT BE DETERMINED.
Description of Event or Problem · 1
A STERILE TIBIA PLATE WAS RECEIVED WITH A HOLE IN THE PACKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9281 | 3.5MM VA-LCP PROX TIBIA PLATE LARGE BEND/12H/207MM/RT-STER | 3.5MM VA-LCP PROX TIB PL LGE BEND/12H/207MM/R-STER | HRS | SYNTHES GMBH | 7958650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |