FDA Adverse Event
Injury
Summary report: N
TI MATRIX LOCKING CAP
MDR report key: 2062605
·
Received April 8, 2011
Report
- Report Number
- 8030965-2011-00160
- Event Type
- Injury
- Date Received
- April 8, 2011
- Date of Event
- February 2, 2011
- Report Date
- February 7, 2011
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- NKB
- PMA / PMN Number
- K100952
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WITHOUT A LOT NUMBER, SYNTHES IS UNABLE TO PROVIDE THE DATE OF MFR. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED AND NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
A DEVICE REPORT FROM WALDENBURG INDICATES A PT IN GERMANY WAS IMPLANTED A SCREW AND LOCKING CAP. THE LOCKING CAP WAS FOUND TO HAVE PULLED AWAY FROM THE SCREW HEAD. SURGICAL INTERVENTION WAS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI MATRIX LOCKING CAP | MATRIX LOCKING CAP | NKB | SYNTHES BRANDYWINE | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |