MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for 10MM SCREW manufactured by Kls Martin Lp.
[141500763]
The kls screw broke off during a surgical procedure of the mandible. Surgeon removed the remaining screw part from the mandible. No pt harm or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085682 |
| MDR Report Key | 8496850 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-03-22 |
| Date Added to Maude | 2019-04-09 |
| 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 | 10MM SCREW |
| Generic Name | SCREW, FIXATION, INTRAOSSEOUS |
| Product Code | DZL |
| Date Received | 2019-04-08 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KLS MARTIN LP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |