CORTSCR Ø4.5 SELF-TAP L42 SST
Report
- Report Number
- 8030965-2013-04072
- Event Type
- Malfunction
- Date Received
- June 25, 2013
- Date of Event
- May 8, 2012
- Report Date
- May 8, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWC
- PMA / PMN Number
- K112583
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE VISUAL INSPECTION AND INVESTIGATION HAS SHOWN THAT THESE ARTICLES HAVE BEEN LABELED INCORRECTLY. THE LABEL SAYS 208.050 / 7755662 BUT IT SHOULD BE 214.742 / 7759050. OBVIOUSLY THIS PACKAGE PASSED THE LABELING PROCEDURE DURING MANUFACTURING PROCESS WITHOUT HAVING GONE THROUGH PROPER CONTROL. THIS COMPLAINT HAS BEEN DETERMINED TO BE VALID. A CAPA DETERMINATION REQUEST HAS BEEN INITIATED. (B)(6).
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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.
LABEL IS 2083050 MATERIAL IS 214.842. THIS IS 2 OF 3 REPORTS FOR THIS COMPLAINT (B)(4).
LABEL IS 208.050 MATERIAL IS 214.842.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287570 | CORTSCR Ø4.5 SELF-TAP L42 SST | HWC | SYNTHES GMBH | 7759050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |