MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for PEDIGUARD CURV PEDIGUARD CURV XS P1-AU451 manufactured by Spineguard.
[125471795]
Surgeon was using a spineguard disposable device and the tip bent; a second item was obtained and the tip bent also while under use. The devices were intact after use and were sequestered. Two spinegard pedicle finder device tips bent during use in a spinal case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8018593 |
| MDR Report Key | 8018593 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-07-12 |
| Report Date | 2018-10-25 |
| Date Reported to FDA | 2018-10-25 |
| Date Reported to Mfgr | 2018-10-30 |
| Date Added to Maude | 2018-10-30 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEDIGUARD CURV |
| Generic Name | NEUROSURGICAL NERVE LOCATOR |
| Product Code | PDQ |
| Date Received | 2018-10-30 |
| Model Number | PEDIGUARD CURV XS |
| Catalog Number | P1-AU451 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINEGUARD |
| Manufacturer Address | 111 HILL ROAD DOUGLASSVILLE PA 19518 US 19518 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-30 |