FDA Adverse Event
Malfunction
Summary report: N
TRUFIT
MDR report key: 3183026
·
Received June 21, 2013
Report
- Report Number
- 1219602-2013-00143
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- March 23, 2012
- Report Date
- May 28, 2013
- Manufacturer
- MANSFIELD MANUFACTURING SITE
- Product Code
- MQV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT IS BEING RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
THE PATIENT HAD SURGERY ON (B)(6) 2011 AND 2- 9MM PLUGS WERE USED. PATIENT REPORTED PAIN AND INSTABILITY IN STUDY KNEE IN (B)(6) 2011, WHICH LED TO A RE-OPERATION (HIGH TIBIAL OSTEOTOMY) ON (B)(6) 2012 (DUE TO PROGRESSIVE OSTEOARTHRITIS). AFTER THE HTO, THIS EVENT WAS RESOLVED ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282654 | TRUFIT | TRUFIT CB PLUG, BLUE, 9MM | MQV | MANSFIELD MANUFACTURING SITE | 72200934 | 50335832 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |