FDA Adverse Event
Other
Summary report: N
HALLUFIX IMPLANT SET
MDR report key: 4220397
·
Received October 28, 2014
Report
- Report Number
- 9615741-2014-00056
- Event Type
- Other
- Date Received
- October 28, 2014
- Date of Event
- October 3, 2014
- Report Date
- October 3, 2014
- Manufacturer
- NEWDEAL SAS
- Product Code
- HRS
- PMA / PMN Number
- K093781
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED THE SURGEON PERFORMED AN MTPJ (METATARSOPHALANGEAL JOINT) FUSION AND A NON-STERILE HALIFAX SCREW WAS OPENED AND IMPLANTED IN THE PATIENT. THIS WAS DISCOVERED POST OPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED BY INTEGRA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 689505 | HALLUFIX IMPLANT SET | NA | HRS | NEWDEAL SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |