MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-28 for ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 5584099 manufactured by Medtronic Sofamor Danek Usa, Inc.
[185811116]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185811117]
Pre op diagnosis: t12-l2 spinal canal stenosis. Procedure performed: l2/3 screw removal, t12-l2 laminectomy, t12-l2 plf levels. T12-l2 intra op, tip of the driver broke off during screw insertion to left l2. The bone was very hard and the tip of the driver broke off at the time of inserting the screw, and the screw could not be inserted. It was difficult to perform removal either, therefore, a short rod was inserted to the l2 screw and the set screw was also inserted, after that, the screw was turned counterclockwise with having the rod and screw pressed, then the screw was removed. Then, the screw was inserted. It took about 10 minutes. There were no patient complications as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00389 |
| MDR Report Key | 9892650 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date of Event | 2020-02-29 |
| Date Mfgr Received | 2020-02-29 |
| Device Manufacturer Date | 2015-06-16 |
| Date Added to Maude | 2020-03-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | LXH |
| Date Received | 2020-03-28 |
| Model Number | NA |
| Catalog Number | 5584099 |
| Lot Number | NM15D017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-28 |