MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-02 for IMPLANT PLACEMENT DRIVER manufactured by Biomet 3i.
[74334104]
Product not returned to manufacturer, but dental implant was returned.
Patient Sequence No: 1, Text Type: N, H10
[74334105]
The dentist reported that the unknown implant placement driver did not engage properly to the implant with internal connection and it fall down when doctor was trying to place into patient? S mouth. Another implant with external connection was placed in the same surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2017-00160 |
| MDR Report Key | 6538039 |
| Date Received | 2017-05-02 |
| Date of Report | 2017-07-13 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2017-07-12 |
| Date Added to Maude | 2017-05-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Generic Name | IMPLANT PLACEMENT DRIVER |
| Product Code | NNP |
| Date Received | 2017-05-02 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET 3I |
| Manufacturer Address | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-02 |