MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-21 for INTEGRA MILTEX 430654 QR0005 manufactured by Integra York Pa, Inc..
[83221035]
During right ankle fusion procedure, drill bit broke off and remained in the pt's right ankle. Unable to retrieve fragments of drill, not visible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071690 |
| MDR Report Key | 6806775 |
| Date Received | 2017-08-21 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-07-21 |
| Date Added to Maude | 2017-08-21 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTEGRA MILTEX |
| Generic Name | DRILL BIT |
| Product Code | FNS |
| Date Received | 2017-08-21 |
| Model Number | 430654 |
| Catalog Number | QR0005 |
| ID Number | 4.4 / L220MM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK PA, INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-21 |