MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-01-29 for MANUAL ORTHOPEDIC SURGICAL INSTRUMENT 873-004 manufactured by Medtronic Sofamor Danek Usa, Inc.
[3122416]
It was reported that the guidewire broke during impaction. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[10418692]
(b)(6). (b)(4). Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2013-00274 |
| MDR Report Key | 2932748 |
| Report Source | 05,07 |
| Date Received | 2013-01-29 |
| Date of Report | 2012-12-31 |
| Date of Event | 2012-12-31 |
| Date Mfgr Received | 2012-12-31 |
| Device Manufacturer Date | 2012-12-04 |
| Date Added to Maude | 2013-04-16 |
| 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 | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT |
| Generic Name | CHAIR, SURGICAL, NON-ELECTRICAL |
| Product Code | FZK |
| Date Received | 2013-01-29 |
| Model Number | NA |
| Catalog Number | 873-004 |
| Lot Number | SW12D277 |
| ID Number | NA |
| 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 | 2013-01-29 |