MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-08 for NUVASIVE UNK manufactured by Nuvasive.
[5240823]
Add'l info received on (b)(6) 2014 for report mw5039489: nerve hook used to remove box tip curette from operative site broke at the tip. Tip was unable to be removed. Confirmed by x-ray.
Patient Sequence No: 1, Text Type: D, B5
[15818760]
Box curette tip broke off of shaft and handle of instrument inside pt during procedure. Pt repositioned and instrument tip removed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039489 |
| MDR Report Key | 4325060 |
| Date Received | 2014-12-08 |
| Date of Report | 2014-11-14 |
| Date of Event | 2014-10-21 |
| Date Added to Maude | 2014-12-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUVASIVE |
| Generic Name | BOX TIP CURETTE |
| Product Code | FZS |
| Date Received | 2014-12-08 |
| Model Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE |
| Manufacturer Address | PARAMUS NJ US |
| Brand Name | NUVASIVE NERVE HOOK LARGE, 99 DEGREE |
| Generic Name | NUVASIVE NERVE HOOK |
| Product Code | KWQ |
| Date Received | 2014-12-08 |
| Model Number | 6900517 |
| Lot Number | 119991 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE |
| Manufacturer Address | PARAMUS NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-08 |