FDA Adverse Event
Injury
Summary report: N
PLATE, 8 HOLE JL
MDR report key: 2875291
·
Received December 17, 2012
Report
- Report Number
- 0001032347-2012-00194
- Event Type
- Injury
- Date Received
- December 17, 2012
- Date of Event
- November 30, 2012
- Report Date
- December 4, 2012
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- HRS
- PMA / PMN Number
- PK011076
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE LOT HISTORY OF THE IMPLANTED UNIT IS UNKNOWN, THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. THE REVIEWED EXPLANT INDICATED THAT THE THREAD LOCKING MECHANISM WAS NOT ENGAGED WITH THE PLATE AS INTENDED INDICATING THAT THE SCREWS WERE NOT FULLY SEATED DURING THE ORIGINAL OPERATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
THE PATIENT HAD A REVISION SURGERY DUE TO THE SCREWS BACKING OUT OF THE STERNUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLATE, 8 HOLE JL | BONE PLATE | HRS | BIOMET MICROFIXATION | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |