MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-04 for 3I INCISE ZR COPING SHADE 3 CBZR0103 manufactured by Biomet 3i.
[16304285]
It was reported that the zirconia coping fractured during placement.
Patient Sequence No: 1, Text Type: D, B5
[16444889]
Visual evaluation of the returned coping confirmed that it had fractured. 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
| Report Number | 0001038806-2015-00060 |
| MDR Report Key | 4483181 |
| Report Source | 05 |
| Date Received | 2015-02-04 |
| Date of Report | 2015-01-13 |
| Date Mfgr Received | 2015-01-13 |
| Device Manufacturer Date | 2014-09-10 |
| Date Added to Maude | 2015-03-09 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3I INCISE ZR COPING SHADE 3 |
| Generic Name | ZIRCONIA COPING |
| Product Code | ELZ |
| Date Received | 2015-02-04 |
| Returned To Mfg | 2015-01-15 |
| Catalog Number | CBZR0103 |
| Lot Number | 143439 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-02-04 |