FDA Adverse Event
Injury
Summary report: N
3.5MM RECONSTRUCTION PLATE 16 HOLES L190
MDR report key: 2023852
·
Received March 14, 2011
Report
- Report Number
- 8030965-2011-00078
- Event Type
- Injury
- Date Received
- March 14, 2011
- Date of Event
- January 28, 2011
- Report Date
- February 21, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- KWP
- PMA / PMN Number
- K982322
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS UNABLE TO DETERMINE THE MANUFACTURER AND/OR THE DATE OF MANUFACTURE. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.
Description of Event or Problem · 1
A DEVICE REPORT RECEIVED INDICATES PATIENT STATUS POST RECONSTRUCTION PLATE IMPLANTATION 8 WEEKS POST OP RETURNED TO SURGEON ON AN UNKNOWN DATE WITH AN X-RAY REVEALING A BROKEN PLATE. SURGEON REMOVED THE DEVICE ON (B)(6) 2011, NO SCREWS WERE NOTED AS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM RECONSTRUCTION PLATE 16 HOLES L190 | RECONSTRUCTION PLATES | KWP | SYNTHES GMBH | NA | 3110820 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | SCREW |