MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for PEDIGUARD P1-AU414 manufactured by Orgenix, Llc.
[53777494]
Patient Sequence No: 1, Text Type: N, H10
[53777495]
Spine guard pedicle failed to alert surgeon of pedicle location and depth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5922392 |
| MDR Report Key | 5922392 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-08-22 |
| Date of Event | 2016-08-10 |
| Report Date | 2016-08-22 |
| Date Reported to FDA | 2016-08-22 |
| Date Reported to Mfgr | 2016-08-22 |
| Date Added to Maude | 2016-09-01 |
| 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 |
| 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 |
| Generic Name | STIMULATOR, NERVE |
| Product Code | PDQ |
| Date Received | 2016-09-01 |
| Model Number | P1-AU414 |
| Lot Number | 15494H0072 |
| Device Expiration Date | 2019-06-03 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGENIX, LLC |
| Manufacturer Address | 111 HILL ROAD DOUGLASSVILLE PA 19518 US 19518 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-01 |