FDA Adverse Event
Malfunction
Summary report: N
OCCIPIT-SCR Ø4.5 L8 TAN
MDR report key: 2964190
·
Received February 15, 2013
Report
- Report Number
- 8030965-2013-00485
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- December 27, 2012
- Report Date
- January 18, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- KWP
- PMA / PMN Number
- K091689
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WAS FOUND.
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THIS DEVICE IS STERILIZED BY SYNTHES (B)(4) FOR DISTRIBUTION ONLY IN (B)(4). THIS STERILE DEVICE WAS RECALLED BY SYNTHES (B)(4) UNDER (B)(4) ONLY.
Description of Event or Problem · 1
.A DEVICE REPORT FROM (B)(4) INDICATES A HOSPITAL IN (B)(6) REPORTED: THE SCREW LENGTH IS DIFFERENT FOR THIS SCREW. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68893 | OCCIPIT-SCR Ø4.5 L8 TAN | OCCIPIT-SCREW | KWP | SYNTHES GMBH | 7550383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |