MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1998-01-07 for SURGICAL TOOL NAVIGATOR (STN) * manufactured by Carl Zeiss.
[19776151]
On 11/21/97, dr began procedure using a zeiss stn system. He was performing an anterior thoracic t-11 corpectomy and fusion with instrumentation. Physician placed drf in an unconventional manner, and was advised that it may affect accuracy. The physician proceeded. The physician then referenced the system, and was satisfied with the accuracy of the system. Two mfr reps from du puy and synthes, were also involved in the case and were advising the physician on the use of their instrumentation. Dr checked approaches sporadically throughout the case and continued to proceed. After all instrumentation was implanted, anterior-posterior x-ray allegedly revealed that a pedicle screw was positioned incorrectly. It allegedly appeared that the screw was misdirected by the cage. Physician believes that the cage may have modified the position of the pt's spinal anatomy. The dr corrected the misdirected screw. Pt allegedly suffered temporary post surgical paralysis due to alleged injury when the pedicle screw entered the spinal canal and cord. Pt is much improved and walking as of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2431026-1998-00001 |
| MDR Report Key | 141842 |
| Report Source | 05,07 |
| Date Received | 1998-01-07 |
| Date of Report | 1998-01-07 |
| Date of Event | 1997-11-21 |
| Date Mfgr Received | 1997-12-02 |
| Date Added to Maude | 1998-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL TOOL NAVIGATOR (STN) |
| Generic Name | IMAGE GUIDED SURGERY DEVICE |
| Product Code | FWD |
| Date Received | 1998-01-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | LOCALIZER-235865 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 138386 |
| Manufacturer | CARL ZEISS |
| Manufacturer Address | CARL ZEISS STRASSE 2-60 OBERKOCHEN GM 73446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-01-07 |