FDA Adverse Event
Summary report: N
*
MDR report key: 1931734
·
Received December 16, 2010
Report
- Report Number
- 1931734
- Date Received
- December 16, 2010
- Date of Event
- December 9, 2010
- Report Date
- December 14, 2010
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- HXX
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
SURGEON WAS IN THE PROCESS OF PERFORMING A PEDICLE SCREW FIXATION UNDER LATERAL FLUOROSCOPIC CONTROL. WHEN APPLYING THE LEFT SACRAL VERTEBRAL (S1) SCREW, THE SCREW APPLICATOR BROKE. IT WAS THE FLANGE THAT HELD THE APPLICATOR INTO THE SCREW THAT BROKE. BECAUSE OF THIS THE SCREWDRIVER WAS DISPLACED MEDIALLY AND RESULTED IN A 1 CM DURAL LACERATION. THIS WAS DURING A LUMBAR LAMINECTOMY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================AS DESCRIBED ABOVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | SCREWDRIVER | HXX | MEDTRONIC SOFAMOR DANEK | 836-015 | 8361011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |