RADIOLUCENT TRANSVERSE CERVICAL RETRACTOR
Report
- Report Number
- 8030965-2013-03237
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Report Date
- May 20, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- GAD
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL INFORMATION THE LOT NUMBER PROVIDED COULD NOT BE VERIFIED; THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. PLACEHOLDER.
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE ADDITIONAL EVALUATION VISUAL INSPECTION OF THE COMPLAINT LOCKING SCREW HAS SHOWN THAT THE WING NUT IS MISSING COMPLETELY. AFTERWARDS, UNFORTUNATELY, WE CANNOT EXACTLY COMPREHEND THE REASON FOR THE APPEARED EVENT. WE CAN ONLY PRESUME THAT THE DAMAGE COULD OCCUR DUE TO A BRIEF EXCESSIVE USAGE.
IT WAS REPORTED THAT THE WING NUT FELL OFF DURING A PROCEDURE AND COULD NOT BE FOUND. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291112 | RADIOLUCENT TRANSVERSE CERVICAL RETRACTOR | GAD | SYNTHES GMBH | AS25650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |