FDA Adverse Event
Other
Summary report: N
SMARTSCREW
MDR report key: 371355
·
Received January 7, 2002
Report
- Report Number
- 9613278-2001-00013
- Event Type
- Other
- Date Received
- January 7, 2002
- Report Date
- June 30, 2001
- Manufacturer
- BIONX IMPLANTS LTD.
- Product Code
- MAI
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
LARGE OSTEOCHONDRAL DEFECT IN THE ANTEROLATERAL ASPECT OF THE MEDIAL FEMORAL CONDYLE WAS FIXED WITH 2.7 AND 3.5MM SMARTSCREWS. EIGHT MONTHS POSTOPERATIVELY IN REPEAT ARTHROSCOPY THE PT WAS FOUND TO HAVE SCREW HEAD FLOATING FREE WITHIN THE PT'S JOINT. AFTER REMOVAL OF THESE LOOSE FRAGMENTS, THE PT HAS RESOLUTION OF SYMPTOMS AND IMPROVED CLINICALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTSCREW | BIOABSORBABLE BONE FIXATION IMPLANT | MAI | BIONX IMPLANTS LTD. | 3.5 MM IN DIAMETER | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention |