FDA Adverse Event
Malfunction
Summary report: N
NI
MDR report key: 2024009
·
Received March 14, 2011
Report
- Report Number
- 8030965-2011-00079
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Date of Event
- January 25, 2011
- Report Date
- February 24, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWC
- PMA / PMN Number
- NI
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
SUBJECT DEVICE NOT EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE MANUFACTURE, PMA/510K NUMBER AND/OR THE DATE OF MANUFACTURE, AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
A DEVICE REPORT RECEIVED FROM OBERDORF INDICATES THAT DURING A PROCEDURE TWO CORTEX SCREWS BROKE WHILE BEING INSERTED. SURGEON WAS UNABLE TO RETRIEVE THE FRAGMENTS AND THE SHAFTS OF THE TWO SCREWS REMAIN IN THE PATIENT. THIS IS ONE OF TWO REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NI | CORTEX SCREW | HWC | SYNTHES GMBH | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | PLATE |