MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-10-14 for 10NM TORQUE LIMITING RATCHET 03.620.061 manufactured by Synthes Monument.
[1832334]
Surgeon performed three lumbar fusions and noted the screw head came out of the rod with the locking cap still in place and the screw head was rotated. Surgeon is not removing the hardware at this time for the three procedures.
Patient Sequence No: 1, Text Type: D, B5
[8771863]
Subject device has been used multiple times in multiple procedures. Subject device is an instrument and is not implanted or explanted. The investigation could not be completed, no conclusion could be drawn, as the product has been returned and is entering the eval system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2010-00295 |
| MDR Report Key | 1875082 |
| Report Source | 05,07 |
| Date Received | 2010-10-14 |
| Date of Report | 2010-09-22 |
| Date Mfgr Received | 2010-09-22 |
| Device Manufacturer Date | 2008-07-07 |
| Date Added to Maude | 2011-04-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHERRY LAING |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVE. |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 10NM TORQUE LIMITING RATCHET |
| Generic Name | TORQUE LIMITING RATCHET |
| Product Code | GFC |
| Date Received | 2010-10-14 |
| Returned To Mfg | 2010-10-01 |
| Model Number | NA |
| Catalog Number | 03.620.061 |
| Lot Number | 80377-116 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-14 |