FDA Adverse Event
Other
Summary report: N
2.4MM STERNALOCK 12 HOLE, LADDER PLATE
MDR report key: 1022548
·
Received March 27, 2008
Report
- Report Number
- 1032347-2008-00009
- Event Type
- Other
- Date Received
- March 27, 2008
- Report Date
- February 22, 2008
- Manufacturer
- BIOMET MICROFIXATION, INC.
- Product Code
- HRS
- PMA / PMN Number
- K011076
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFO 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
RECEIVED A BROKEN EXPLANTED PLATE. NO ADDITIONAL INFO HAS BEEN REC'D.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2.4MM STERNALOCK 12 HOLE, LADDER PLATE | BONE PLATE | HRS | BIOMET MICROFIXATION, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization | UNK WHICH SCREWS OR HOW MANY WERE USED| SCREWS WOULD HAVE BEEN USED TO FIXATE THE PLATE |