FDA Adverse Event
Malfunction
Summary report: N
VERSALOK UNLOCKER
MDR report key: 286200
·
Received July 17, 2000
Report
- Report Number
- 2246640-2000-00001
- Event Type
- Malfunction
- Date Received
- July 17, 2000
- Date of Event
- May 1, 2000
- Report Date
- June 16, 2000
- Manufacturer
- OSTEOTECH, INC.
- Product Code
- MNI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SURGEON WAS PERFORMING PROCEDURE TO EXPLANT VERSLOK SCREWS AND RODS BECAUSE SUCCESSFUL SPINAL FUSION HAD BEEN ACHIEVED AND IMPLANTS WERE NO LONGER NECESSARY. WHILE SURGEON WAS USING VERSALOK UNLOCKER INSTRUMENT TO UNLOCK VERSALOCK SCREWS FROM RODS IN PT, HANDLE OF UNLOCKER INSTRUMENT BROKE, NECESSITATING THE USE OF OTHER INSTRUMENT(S) TO DISENGAGE SCREWS FROM RODS AND RESULTING IN A DELAY IN COMPLETING THE PROCEDURE. SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE PROCEDURE. PT WAS REPORTED ON 7/13 TO BE DOING FINE, WITH NO SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSALOK UNLOCKER | ACCESSORY FOR POSTERIOR SPINAL FIXATION DEVICE | MNI | OSTEOTECH, INC. | NA | A077252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | (UNK TO 05/2000 (CONTIN)).| VERSALOK LOW BACK FIXATION SYSTEM, |