FDA Adverse Event
Injury
Summary report: N
BIOINTRAFIX SCREW
MDR report key: 1061683
·
Received June 16, 2008
Report
- Report Number
- 1221934-2008-00306
- Event Type
- Injury
- Date Received
- June 16, 2008
- Report Date
- April 7, 2008
- Manufacturer
- DEPUY MITEK
- Product Code
- MBI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MITEK IS IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD IS HAD AND EVALUATED, THE RESULTS OF THAT INVESTIGATION WILL BE SUBJECT OF THE FOLLOW-UP REPORT.
Description of Event or Problem · 1
OUR AFFILIATE REPORTS THAT A PT HAD A KNEE REPAIR SOMETIME IN 2005 OR 2006, WITH THE USE OF A BIOINTRAFIX SCREW AND SHEATH FOR TIBIAL FIXATION. APPROX 2 TO 3 YEARS LATER, IN 2008, THE PT PRESENTED WITH PAIN. AT APPROX THE SAME TIME FRAME, THE PT WAS EXAMINED, WE ASSUME THAT THE SITE WAS REVISITED SURGICALLY. THE SURGEON NOTED THAT THERE WAS "GRANULOSIS" AT THE SITE OF THE TIBIAL TUNNEL. THE SURGEON ALSO NOTED THAT THE SHEATH WAS NO LONGER PRESENT. THIS IS ALL OF THE INFO THAT HAS BEEN MADE AVAILABLE, THERE ARE QUESTIONS OUT TO THE COMPLAINT AUTHOR ASKING FOR FURTHER INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOINTRAFIX SCREW | SOFT TISSUE FIXATION DEVICE | MBI | DEPUY MITEK | 254624 | 0505165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other| R |