FDA Adverse Event
Injury
Summary report: N
TSRH SPINAL FIXATION SYSTEM
MDR report key: 224183
·
Received May 19, 1999
Report
- Report Number
- 1030489-1999-00053
- Event Type
- Injury
- Date Received
- May 19, 1999
- Date of Event
- June 29, 1992
- Report Date
- April 20, 1999
- Manufacturer
- SOFAMOR DANEK MANUFACTURING
- Product Code
- KWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IMPLANT DATE: 4/17/1992. POST-OPERATIVE X-RAYS (APPROX 2 MONTHS) REVEALED THAT THE BONE SCREW ON THE LEFT HAD MOVED BUT WAS NOT COMPROMISING ANYTHING. REVISION SURGERY ON 6/29/1992 TO REMOVE AND REPLACE PART OF THE HARDWARE AT WHICH TIME IT WAS NOTED THAT THE INSTRUMENTATION WAS TIGHT AND NON-MOBILE. THE L4 SCREWS WERE REMOVED TO ACCESS THE FORAMEN. PT RE-INJURED LOWER BACK AND EXPERIENCED PAIN. REVISION SURGERY TO REMOVE THE REST OF THE HARDWARE ON 1/19/1993.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TSRH SPINAL FIXATION SYSTEM Implant | SPINAL FIXATION SYSTEM | KWP | SOFAMOR DANEK MANUFACTURING | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |