FDA Adverse Event
Other
Summary report: N
MENISCUS ARROW
MDR report key: 569399
·
Received January 11, 2005
Report
- Report Number
- 9613278-2005-00004
- Event Type
- Other
- Date Received
- January 11, 2005
- Date of Event
- December 27, 2004
- Report Date
- January 10, 2005
- Manufacturer
- LINVATEC BIOMATERIALS, INC.
- Product Code
- MAI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
IMPLANTS WERE INSERTED IN 2004 AND AFTER IMPLANTATION THEY NOTICED EXPIRATION DATING OF PACKAGE, END OF JAN. 2004 (01/2004). HOWEVER, UP TO DATE NO POST-OPERATIVE COMPLIATIONS REFERRING TO THIS CASE, ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MENISCUS ARROW | BIOABSORBABLE SOFT TISSUE FIXATION DEVICE | MAI | LINVATEC BIOMATERIALS, INC. | 531110 | S0216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |