MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-16 for FIXTURE REMOVER SCREW M2.0 FRS20 manufactured by Neobiotech Co. Ltd..
[62534012]
The dentist reported that fixture remover screw fractured in the attempt to extract the implant. The dentist milled out the implant to achieve the removal. Patient was re-scheduled for another surgery for re-implantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2016-00345 |
| MDR Report Key | 6180394 |
| Date Received | 2016-12-16 |
| Date of Report | 2016-11-24 |
| Date of Event | 2015-11-06 |
| Date Facility Aware | 2016-11-24 |
| Report Date | 2016-11-25 |
| Date Reported to Mfgr | 2016-11-25 |
| Date Added to Maude | 2016-12-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXTURE REMOVER SCREW M2.0 |
| Generic Name | FIXTURE REMOVED SCREW |
| Product Code | DZA |
| Date Received | 2016-12-16 |
| Catalog Number | FRS20 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOBIOTECH CO. LTD. |
| Manufacturer Address | E-SPACE #105 212-26 GURO-DONG GURO-GU, SEOUL 152-189 KS 152-189 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-16 |