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 9560524 manufactured by Medtronic Sofamor Danek Usa, Inc.
[186552371]
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
[186552372]
It was reported that the patient underwent micro-endoscopic discectomy. Intra-op, the flex arm could not be fixed firmly even though the cable tightening wheel was turned. The product was continued to be used in the operation and the operation was finished. The sales rep had provided guidance for lubrication and draw-bar adjustment. No patient complications were reported as a result of this event. Upon checking the instrument, the handle screw of the flex arm was found to be worn near the thread center to the root.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00393 |
| MDR Report Key | 9894719 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-08-14 |
| 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 | 9560524 |
| Lot Number | MY19G001 |
| 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 |