FDA Adverse Event
Other
Summary report: N
QWIX FIXATION SCREW 4.3MM DIAMETER X 44MM LENGTH
MDR report key: 4433177
·
Received January 13, 2015
Report
- Report Number
- 9615741-2014-00070
- Event Type
- Other
- Date Received
- January 13, 2015
- Date of Event
- December 12, 2014
- Report Date
- December 16, 2014
- Manufacturer
- NEWDEAL SAS
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED SINCE IT WAS IMPLANTED. BASED ON REPORTED INFORMATION, INTEGRA HAS INITIATED AN INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED AN EXPIRED QWIX 4.3 SCREW (OF THEIR CONSIGNMENT) HAS BEEN IMPLANTED IN PATIENT ON (B)(6). IT WAS REPORTED THERE WAS NO MEDICAL DEVICE FAILURE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. ALLEGATION OF PATIENT INJURY OR DEATH IS INDICATED AS "UNKNOWN." ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30013 | QWIX FIXATION SCREW 4.3MM DIAMETER X 44MM LENGTH | QUIX | HSB | NEWDEAL SAS | EGXA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |