FDA Adverse Event
Injury
Summary report: N
ORTHADAPT BIOIMPLANT
MDR report key: 1522281
·
Received November 2, 2009
Report
- Report Number
- 3005147058-2009-00059
- Event Type
- Injury
- Date Received
- November 2, 2009
- Date of Event
- August 8, 2008
- Report Date
- October 19, 2009
- Manufacturer
- PEGASUS BIOLOGICS, INC.
- Product Code
- FTM
- PMA / PMN Number
- K071065
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE AVAILABLE CASE INFORMATION, THE REPORTED RE-RUPTURE IS DUE TO TRAUMA AND IS NOT GRAFT-RELATED. THE MANUFACTURER OF THE DEVICE AT THE TIME WAS PEGASUS BIOLOGICS, INC. SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC. IS THE REPORTING COMPANY FOR THE EVENT. THE EVENT OCCURRED PRIOR TO SYNOVIS ACQUIRING PEGASUS BIOLOGICS.
Description of Event or Problem · 1
PATIENT HAD ACHILLES TENDON REPAIR WITH ORTHADAPT AUGMENTATION. PATIENT EXPERIENCED A RE-INJURY TO THE ACHILLES TENDON IN A FALL APPROXIMATELY 77 DAYS POST REPAIR. PHYSICIAN EXPLANTED THE GRAFT APPROXIMATELY 91 DAYS POST-REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHADAPT BIOIMPLANT | SURGICAL MESH | FTM | PEGASUS BIOLOGICS, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Hospitalization |