FDA Adverse Event
Injury
Summary report: N
MINILOK QA PLUS 2/0, W/ORTHOCORD
MDR report key: 2113494
·
Received May 31, 2011
Report
- Report Number
- 1221934-2011-00216
- Event Type
- Injury
- Date Received
- May 31, 2011
- Report Date
- May 13, 2011
- Manufacturer
- DEPUY MITEK
- Product Code
- MBI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.
Description of Event or Problem · 1
OUR REP IS REPORTING TO US THAT THE PATIENT UNDERWENT A SUCCESSFUL THUMB REPAIR WITH THE USE OF A MINILOK QA PLUS FOR FIXATION ON (B)(6) 2011. APPROXIMATELY 6 WEEKS POST-OP, AT A FOLLOW-UP VISIT, THE PATIENT PRESENTED WITH SWELLING AND REDNESS. CULTURES WERE TAKEN AND TESTED NEGATIVE; SURGEON THINKS THAT THE PATIENT MAY BE HAVING A REACTION TO THE FIXATION DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINILOK QA PLUS 2/0, W/ORTHOCORD | SOFT TISSUE DEVICE | MBI | DEPUY MITEK | 212853 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |