FDA Adverse Event
Summary report: N
COMPRESSX COMPRESSION SCREW
MDR report key: 2543031
·
Received April 13, 2012
Report
- Report Number
- 3007289093-2012-00004
- Date Received
- April 13, 2012
- Date of Event
- April 3, 2011
- Report Date
- April 13, 2012
- Manufacturer
- EXTREMITY MEDICAL LLC
- Product Code
- HWC
- PMA / PMN Number
- K081934
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SURGEON PERFORMED A REMOVAL CASE BECAUSE THE SCREW WAS BACKING OUT. 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 DUE TO NON-UNION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPRESSX COMPRESSION SCREW | SCREW, FIXATION, BONE | HWC | EXTREMITY MEDICAL LLC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |