FDA Adverse Event
Malfunction
Summary report: N
LACTOSORB PECTUS STABILIZER
MDR report key: 1170265
·
Received September 10, 2008
Report
- Report Number
- 1032347-2008-00056
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- July 6, 2008
- Report Date
- August 15, 2008
- Manufacturer
- BIOMED MICFORFIXATION
- Product Code
- HRS
- PMA / PMN Number
- K071577
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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
ONE PECTUS BAR & TWO LACTOSORB PECTUS STABILIZERS IMPLANTED IN 2008. APPROXIMATELY 1 WEEK AFTER DISCHARGE, THE MAIN BAR PARTIALLY FLIPPED. AT REEXPLORATION, THE STABILIZER ON EACH SIDE HAD BUCKLED (FORCED A Z CONFIGURATION). REVISION SURGERY WAS PERFORMED, ALL HARDWARE WAS REMOVED, A NEW BAR WITH TWO METAL STABILIZERS WERE PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LACTOSORB PECTUS STABILIZER | RESORBABLE STABILIZER | HRS | BIOMED MICFORFIXATION | 877870 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |