MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-26 for FIXTURE REMOVER SCREW M 2.0 FRS20 manufactured by Neobiotech.
[53093780]
The dentist reported that during the procedure to remove an unknown implant the fixture remover screw (frs20) fractured and stuck inside the fixture remover (fr415). The dentist completed the removal of the implant surgically.
Patient Sequence No: 1, Text Type: D, B5
[55481729]
Patient Sequence No: 1, Text Type: N, H10
[55481730]
The dentist reported that during the procedure to remove a non-zimmer biomet implant the fixture remover screw (frs20) fractured and broke off inside the implant. The fractured portion of the remover screw became stuck in the fixture remover (fr415). The dentist completed the removal of the implant surgically.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2016-00216 |
| MDR Report Key | 5906114 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-26 |
| Date of Report | 2016-08-09 |
| Date of Event | 2016-08-09 |
| Date Facility Aware | 2016-08-09 |
| Report Date | 2016-08-26 |
| Date Reported to FDA | 2016-08-26 |
| Date Reported to Mfgr | 2016-09-21 |
| Date Mfgr Received | 2016-08-09 |
| Date Added to Maude | 2016-08-26 |
| 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 M 2.0 |
| Generic Name | IMPLANT REMOVAL SCREW |
| Product Code | DZA |
| Date Received | 2016-08-26 |
| Returned To Mfg | 2016-08-19 |
| Catalog Number | FRS20 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOBIOTECH |
| Manufacturer Address | E-SPACE # 1010, 212-26 GURO-DONG, GURO-GU, SEOUL FL KS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-26 |