FDA Adverse Event
Injury
Summary report: N
DYNESYS STABLIZING CORD 100/150/200
MDR report key: 1521988
·
Received October 20, 2009
Report
- Report Number
- 9613350-2009-00604
- Event Type
- Injury
- Date Received
- October 20, 2009
- Date of Event
- September 1, 2009
- Report Date
- September 18, 2009
- Manufacturer
- ZIMMER GMBH
- Product Code
- NQP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SURGEON WOULD LIKE AN INVESTIGATION FOR DURABILITY AFTER 7 YEARS AND 2 MONTHS. DUE TO PAIN, THE PRODUCTS WERE REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DYNESYS STABLIZING CORD 100/150/200 | DYNESYS TOP-LOADING SPINAL SYSTEM | NQP | ZIMMER GMBH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R | DYNESYS UNIVERSAL SPACER 6-45 (REF 01.03706.045,| DYNESYS PEDICLE SCREW (REF 01.03764.050,| LOT 2094751)| LOT UNKNOWN) |