FDA Adverse Event
Injury
Summary report: N
MOE SQUARE-END SPINAL DISTRACTION ROD
MDR report key: 253603
·
Received December 7, 1999
Report
- Report Number
- 1822565-1999-00132
- Event Type
- Injury
- Date Received
- December 7, 1999
- Date of Event
- October 27, 1999
- Report Date
- October 29, 1999
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSB
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT HAD RODS IMPLANTED IN 1994. ONE ROD FRACTURED AT L1 REQUIRING REMOVAL OF HARDWARE, EXPLORATION OF FUSION AND NEED FOR NEW BONE GRAFT AND HARDWARE INSERTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOE SQUARE-END SPINAL DISTRACTION ROD Implant | SPINAL ROD | HSB | ZIMMER, INC. | NA | 55476700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |