FDA Adverse Event
Injury
Summary report: N
8-10MMX 30MM INTRAFIX TAPERED
MDR report key: 548659
·
Received October 15, 2004
Report
- Report Number
- 1221934-2004-00136
- Event Type
- Injury
- Date Received
- October 15, 2004
- Date of Event
- September 21, 2004
- Report Date
- September 28, 2004
- Manufacturer
- DEPUY MITEK
- Product Code
- MBI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACL SURGERY IN NOVEMBER 2003, FISTULA FORMATION AND EMERGENCY ADMISSION IN MAY 2004, OPERATION FOR FISTULA REMOVAL IN MAY 2004. (AT THIS POINT IT DOES NOT SEEM THAT THE MEDICAL TEAM INVOLVED HAS MADE A CORRELATION BETWEEN THE ADVERSE EVENT AND THE PRODUCT.... AFRIGUALT 2004 09:17:21 AM) REPEATED EMERGENCY ADMISSION WITH SAME DIAGNOSIS ON 31 AUGUST, OPERATION FOR FISTULA REMOVAL AND REMOVE OF THE IMPLANT ON 2 SEPTEMBER 2004. (AT THIS POINT THE MEDICAL TEAM PERFORMS THE SAME INTERVENTION WITH THE ADDITION OF REMOVING THE INTREPID SCREW.....10/2004 09:17:06 AM)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8-10MMX 30MM INTRAFIX TAPERED | SOFT TISSUE FIXATION DEVICE | MBI | DEPUY MITEK | 254603 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |