MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-01-03 for MSD - UNK INSTRUMENT manufactured by Medtronic Sofamor Danek Instrument Manuf.
[776341]
It was reported that an instrument broke intraoperatively. An x-ray taken several weeks post-op revealed that the broken piece reportedly remained inside of the operative site. A revision surgery was performed to removed the broken piece. No add'l patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[8037240]
Neither the device nor films of applicable imaging studies were returned to the mfr for evaluation. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2008-00005 |
| MDR Report Key | 975482 |
| Report Source | 06 |
| Date Received | 2008-01-03 |
| Date of Report | 2007-12-04 |
| Date of Event | 2007-05-08 |
| Date Mfgr Received | 2007-01-04 |
| Date Added to Maude | 2008-01-15 |
| 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 | CHRISTINE SCIFERT, M.S. |
| Manufacturer Street | 1800 PYRAMID PL |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUF |
| Manufacturer Street | 2075 BROTHER BLVD. |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MSD - UNK INSTRUMENT |
| Generic Name | UNK INSTRUMENT |
| Product Code | GZX |
| Date Received | 2008-01-03 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 946150 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUF |
| Manufacturer Address | 2975 BROTHER BLVD BARTLETT TN 38113 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-03 |