MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for 5101-90131 manufactured by K2m.
[143989640]
Doctor was using a cannulated pedicle awl at the level of l5, right side. While using this awl the tip of the instrument sheared off in the right pedicle of l5. The doctor was leaving the instrument tip as a retained foreign body from the patient. Vendor was on site and took device into his possession immediately, before i was able to assess. Details listed under device were direct from vendor. I was unable to find a match in access gudid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8577255 |
| MDR Report Key | 8577255 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-15 |
| Report Date | 2019-04-22 |
| Date Reported to FDA | 2019-04-22 |
| Date Reported to Mfgr | 2019-05-03 |
| Date Added to Maude | 2019-05-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Generic Name | CANNULATED PEDICLE PROBE |
| Product Code | HXB |
| Date Received | 2019-05-03 |
| Returned To Mfg | 2019-04-15 |
| Model Number | 5101-90131 |
| Lot Number | FGXN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | K2M |
| Manufacturer Address | 600 HOPE PARKWAY SE LEESBURG VA 20175 US 20175 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-03 |