FDA Adverse Event
Other
Summary report: N
LORENZ PECTUS SUPPORT BAR, 14IN
MDR report key: 927925
·
Received October 4, 2007
Report
- Report Number
- 1032347-2007-00025
- Event Type
- Other
- Date Received
- October 4, 2007
- Report Date
- September 21, 2007
- Manufacturer
- BIOMET MICROFIXATION, INC.
- Product Code
- HRS
- PMA / PMN Number
- K972420
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADD'L 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LORENZ PECTUS SUPPORT BAR, 14IN | PECTUS BAR | HRS | BIOMET MICROFIXATION, INC. | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | A STABLIZER MAY HAVE BEEN USED TO SECURE THE BAR |