FDA Adverse Event
Malfunction
Summary report: N
ULTRAFIX RC
MDR report key: 263305
·
Received February 14, 2000
Report
- Report Number
- 1223420-2000-00002
- Event Type
- Malfunction
- Date Received
- February 14, 2000
- Date of Event
- January 21, 2000
- Report Date
- February 14, 2000
- Manufacturer
- LI MEDICAL TECHNOLOGIES, INC.
- Product Code
- KGS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AT THREE AND ONE-HALF MONTHS POST-OPERATIVELY, THE PT WAS PERFORMING OVERHEAD WEIGHTLIFTING WHEN PT HEARD A 'POP' AND THE SITE OF THE SURGERY TURNED BLACK AND BLUE. THE INDIVIDUAL AFTER THIS INCIDENT COULD NOT RAISE THE ARM. THREE WEEKS AFTER THIS EVENT PT WAS RE-OPERATED ON. THE ANTERIOR ULTRA-FIX RC ANCHOR HAD THE STITCH BROKEN. THE POSTERIOR ANCHOR HAD PULLED OUT OF THE BONE AND THE STITCH WAS BROKEN AS WELL. THE ANCHOR WAS FOUND IN SOFT TISSUE AND REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRAFIX RC | SUTURE ANCHOR | KGS | LI MEDICAL TECHNOLOGIES, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |