MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-28 for FIXTURE REMOVER SCREW M2.0 FRS20 manufactured by Neobiotech Co. Ltd..
[60990644]
Device was discarded by dentist.
Patient Sequence No: 1, Text Type: N, H10
[60990645]
The dentist reported that the fixture removal screw fractured within the implant. The screw fragment was removed and the implant remains placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2016-00315 |
| MDR Report Key | 6130271 |
| Date Received | 2016-11-28 |
| Date of Report | 2016-10-28 |
| Report Date | 2016-11-09 |
| Date Reported to Mfgr | 2016-11-09 |
| Date Mfgr Received | 2016-10-28 |
| Date Added to Maude | 2016-11-28 |
| 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 Contact | MS. DANIA PEREZ |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5617766700 |
| Manufacturer G1 | BIOMET 3I |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXTURE REMOVER SCREW M2.0 |
| Generic Name | FIXTURE REMOVER SCREW |
| Product Code | DZA |
| Date Received | 2016-11-28 |
| Catalog Number | FRS20 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOBIOTECH CO. LTD. |
| Manufacturer Address | E-SPACE #105 212-26 GURO-DONG GURO-GU, SEOUL FL 152-789 KS 152-789 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-28 |