FDA Adverse Event
Injury
Summary report: N
MITEK, 30MM INTRAFIX TIBIAL SHEATH
MDR report key: 411982
·
Received August 22, 2002
Report
- Report Number
- 1221934-2002-00073
- Event Type
- Injury
- Date Received
- August 22, 2002
- Manufacturer
- MITEK WORLDWIDE
- Product Code
- MBI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT HAD AN ACL REPAIR USING THE MITEK, RIGIDFIX AND INTRAFIX DEVICES IN 2002. PT EXPERIENCED POST-OP SWELLING. KNEE WAS ASPIRATED THREE TIMES REMOVING STRAW COLORED FLUID. IN 7/2002 DR PERFORMED A SECOND PROCEDURE AND DID DEBRIDEMENT & WASHOUT OF THE SITE. THE ACL LOOKED GOOD. CULTURES CAME BACK NEGATIVE FOR INFECTION. AS SURGICAL INTERVENTION OCCURRED AN MDR IS BEING FILED TO DOCUMENT THIS EVENT. SEE ALSO MDR # 1221932-2002-00074 & 1221934-2002-00075.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MITEK, 30MM INTRAFIX TIBIAL SHEATH | FASTENER, FIXATION DEVICE | MBI | MITEK WORLDWIDE | 254601 | 0112028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |