FDA Adverse Event
Injury
Summary report: N
IO FIX FUSION DEVICE
MDR report key: 2542593
·
Received April 13, 2012
Report
- Report Number
- 3007289093-2012-00005
- Event Type
- Injury
- Date Received
- April 13, 2012
- Date of Event
- July 16, 2011
- Report Date
- April 13, 2012
- Manufacturer
- EXTREMITY MEDICAL, LLC.
- Product Code
- HWC
- PMA / PMN Number
- K101700
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SURGEON PERFORMED A REMOVAL CASE BECAUSE THE SCREW CONSTRUCT DISENGAGED. THE SCREW WAS NOT RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE LOT CODE IS NOT KNOWN. THROUGH COMMUNICATION WITH THE DISTRIBUTOR, THE ISSUE WAS CAUSED BY PT NON-COMPLIANCE. AT THIS TIME, THE EVENT IS CONSIDERED TO BE CLOSED.
Description of Event or Problem · 1
PT REQUIRED SURGERY TO REMOVE HARDWARE BECAUSE SCREW CONSTRUCT DISENGAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IO FIX FUSION DEVICE | SCREW, FIXATION, BONE | HWC | EXTREMITY MEDICAL, LLC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |