FDA Adverse Event
Other
Summary report: N
STERNALOCK PLATE
MDR report key: 865889
·
Received June 12, 2007
Report
- Report Number
- 1032347-2007-00021
- Event Type
- Other
- Date Received
- June 12, 2007
- Report Date
- June 11, 2007
- Manufacturer
- BIOMET MICROFIXATION, INC.
- Product Code
- HRS
- PMA / PMN Number
- K011076
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENT SALES REPRESENTATIVE HEARD OF TWO PRIOR DOCTORS HAVING A STERNALOCK PLATE BREAK, WHICH RESULTED IN A REVISION SURGERY. THIS OCCURRED WHEN UNDER A PRIOR SALES REPRESENTATIVE TENURE. THE CURRENT REP DOES NOT KNOW WHAT HOSPITAL, WHAT DOCTOR, WHAT PLATE, OR WHEN THIS OCCURRED. ONLY INFORMATION IS: OCCURRED AT TWO DIFFERENT HOSPITALS. 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
PROCEDURE: STERNAL CLOSURE. PLATE BROKE, REVISION SURGERY REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERNALOCK PLATE | BONE PLATE | HRS | BIOMET MICROFIXATION, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization | SCREWS USED TO FIXATE THE PLATE| QUANTITY AND PART # UNK |