FDA Adverse Event
Malfunction
Summary report: N
ULTRAFIX RC
MDR report key: 259507
·
Received January 18, 2000
Report
- Report Number
- 1223420-2000-00001
- Event Type
- Malfunction
- Date Received
- January 18, 2000
- Report Date
- January 14, 2000
- Manufacturer
- LI MEDICAL TECHNOLOGIES, INC.
- Product Code
- MBI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THREE MONTHS POSTOPERATIVELY WAS PERFORMED TO REMOVE ONE ULTRAFIX RC SUTURE ANCHOR. 3 WEEKS POSTOPERATIVE PT FELT PAIN WHEN REACHING. ANCHOR WAS FULLY DEPLOYED ON EXAMINATION. ONE ARM OF FOUR WAS BENT MORE THAN THE OTHER THREE. SURGEON IS A REGULAR USER OF ULTRAFIX PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRAFIX RC | SUTURE ANCHOR | MBI | LI MEDICAL TECHNOLOGIES, INC. | 10139 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |