MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-02-06 for MANUAL ORTHOPEDIC SURGICAL INSTRUMENT 9560631 manufactured by Medtronic Sofamor Danek.
[18513413]
It was reported that the tip of the curette broke off in the disc space of the patient. Surgeon was not able to retrieve it. The tip was left in the disc space. No other patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[18688893]
Device codes: labeled yes. Device was not returned to the manufacturer for evaluation. Unable to determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2008-00051 |
| MDR Report Key | 992716 |
| Report Source | 07 |
| Date Received | 2008-02-06 |
| Date of Report | 2008-01-10 |
| Date of Event | 2008-01-09 |
| Date Mfgr Received | 2008-01-09 |
| Device Manufacturer Date | 2006-12-19 |
| Date Added to Maude | 2008-10-09 |
| 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 | CHAD ASHTON |
| 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 | 2975 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 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT |
| Generic Name | CURRETTE |
| Product Code | HTF |
| Date Received | 2008-02-06 |
| Model Number | NA |
| Catalog Number | 9560631 |
| Lot Number | GZ06L017 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 994107 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Address | 2975 BROTHER BLVD. BARTLETT TN 38133 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-06 |