MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-09 for SYNTHES 03.620.061 manufactured by Synthes.
[1668651]
Pt admitted with dx of lumbar spinal stenosis and spondylolisthesis and had a revision, posterior lumbar decompression, instrumentation, and fusion -l2-s1- on (b)(6) 2010. The rods were tightened in place with the top tightening eye-bolt system of the synthes pangea system which was used in replacement of internal segmental instrumentation. Final torque mechanism was performed on the screws, torque limiting rachet, and the construct was cross linked. On (b)(6) 2010, the md called to report that an x-ray revealed that the rod had telescoped out of the screw. The pt was asymptomatic. On (b)(6) 2010, the md reported that the pt became symptomatic and had experienced a bilateral fixation failure. Pt had emergent surgery on (b)(6) 2010. The instrumentation was removed and replaced by a different company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018166 |
| MDR Report Key | 1899781 |
| Date Received | 2010-11-09 |
| Date of Report | 2010-11-09 |
| Date of Event | 2010-09-22 |
| Date Added to Maude | 2010-11-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNTHES |
| Generic Name | TORQUE LIMITING RATCHET |
| Product Code | GFC |
| Date Received | 2010-11-09 |
| Returned To Mfg | 2010-09-22 |
| Model Number | 03.620.061 |
| Lot Number | 80377-116 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES |
| Manufacturer Address | WEST CHESTER PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-11-09 |