MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-19 for 3I INCISE ZR COPING SHADE 2 N/A CBZR0102 manufactured by Biomet 3i.
[12913702]
The coping has not been returned from the customer. The fracture could not be verified. The device history record review indicated no indication of any manufacturing deviations that would contribute to this event. Through the investigation of this complaint, a definitive root cause could not be determined. There were no manufacturing deviations which may have contributed to the reported fracture.
Patient Sequence No: 1, Text Type: N, H10
[17266200]
The dentist reported that this zirconia coping that was placed in (b)(6) 2014 had fractured in the patient's mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2014-00176 |
| MDR Report Key | 4348219 |
| Report Source | 05 |
| Date Received | 2014-12-19 |
| Date of Report | 2014-12-04 |
| Date Mfgr Received | 2015-01-14 |
| Device Manufacturer Date | 2014-06-30 |
| Date Added to Maude | 2015-01-06 |
| 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 | 0 |
| Event Location | 0 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3I INCISE ZR COPING SHADE 2 |
| Generic Name | ZIRCONIA COPING |
| Product Code | NSP |
| Date Received | 2014-12-19 |
| Model Number | N/A |
| Catalog Number | CBZR0102 |
| Lot Number | 142766 |
| ID Number | N/A |
| Operator | LAY USER/PATIENT |
| 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 | 2014-12-19 |