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 2020-03-21 for SCREWDRIVER 5584111 manufactured by Medtronic Sofamor Danek Usa, Inc.
[184443101]
Product was not 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
[184443102]
It was reported that the patient presented with delayed paralysis after t12 compression fracture; and underwent posterior spinal fusion at t10-l2. Intra-op, screw head was slightly shaking when inserting the screw. The shaft of screw tip did not feel to be wobbling, but the head part seemed to draw an arc and it was uncomfortable to insert the screw. The screw and the driver were confirmed to be firmly gripped and locked before use. There were no patient complications reported as a result of this event. When checking the driver, it was found to be deformed and scratched on the tip of shaft, scratched on the sleeve thread, and the handle joint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00346 |
| MDR Report Key | 9863629 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-21 |
| Date of Report | 2020-03-21 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2014-12-18 |
| Date Added to Maude | 2020-03-21 |
| 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 | SCREWDRIVER |
| Generic Name | SCREWDRIVER |
| Product Code | HXX |
| Date Received | 2020-03-21 |
| Model Number | NA |
| Catalog Number | 5584111 |
| Lot Number | RS14M003 |
| 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 | 2020-03-21 |