FDA Adverse Event
Injury
Summary report: N
HALLU.X INTRAMEDULLARY SCREW SYSTEM
MDR report key: 2542594
·
Received April 13, 2012
Report
- Report Number
- 3007289093-2012-00003
- Event Type
- Injury
- Date Received
- April 13, 2012
- Date of Event
- February 3, 2011
- Report Date
- April 13, 2012
- Manufacturer
- EXTREMITY MEDICAL, LLC.
- Product Code
- HWC
- PMA / PMN Number
- K091577
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SURGEON PERFORMED A REMOVAL CASE BECAUSE OF PT NON-UNION. THE SCREW WAS NOT RETURNED FOR EVALUATION. 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 PT NON-UNION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HALLU.X INTRAMEDULLARY SCREW SYSTEM | SCREW, FIXATION, BONE | HWC | EXTREMITY MEDICAL, LLC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |