FDA Adverse Event
Injury
Summary report: N
VERSALOK ANCHORS
MDR report key: 1180162
·
Received September 29, 2008
Report
- Report Number
- 1221934-2008-00464
- Event Type
- Injury
- Date Received
- September 29, 2008
- Report Date
- September 25, 2008
- Manufacturer
- DEPUY MITEK
- Product Code
- MBI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL OF THE INFORMATION THAT CAN BE HAD, IS HAD AND EVALUATED, A FOLLOW-UP REPORT DETAILING OUR FINDINGS WILL BE FORTHCOMING.
Description of Event or Problem · 1
OUR REP IS REPORTING THAT A PATIENT HAD 2 VERSALOK ANCHOR PULLOUTS AT SOME POINT POST-OP. THE DATE OF THE ORIGINAL SURGERY IS UNKNOWN, IT IS NOT KNOWN HOW THE PATIENT PRESENTED, X-RAYS TAKEN DATED 2008 CLEARLY REVEAL THE ANCHOR PULLOUTS, IT IS NOT KNOWN IF THE RE-SURGERY FOR REMEDY HAS TAKEN PLACE AS YET. QUESTIONS ARE OUT TO OUR REP ASKING FOR DETAIL AND STATUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSALOK ANCHORS | SOFT TISSUE FIXATION DEVICE | MBI | DEPUY MITEK | 210808 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |