MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-05 for 3I INCISE ZR 3 UNIT FRAMEWORK SHADE 4 CBZR0304 manufactured by Biomet 3i.
[5904423]
The lab reported this zirconia coping fractured post restoration.
Patient Sequence No: 1, Text Type: D, B5
[13343241]
Upon inspection, the complaint investigator confirmed this coping has fractured. Incise copings are designed outside of biomet3i control. Device history record and complaint history reviews did not indicate any manufacturing deviations which would cause or contribute to the reported complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001038806-2015-00701 |
| MDR Report Key | 4820606 |
| Report Source | 05 |
| Date Received | 2015-06-05 |
| Date of Report | 2015-05-13 |
| Date Mfgr Received | 2015-05-13 |
| Device Manufacturer Date | 2014-07-11 |
| Date Added to Maude | 2015-06-12 |
| 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 3 UNIT FRAMEWORK SHADE 4 |
| Generic Name | ZIRCONIA COPING |
| Product Code | ELZ |
| Date Received | 2015-06-05 |
| Returned To Mfg | 2015-05-18 |
| Catalog Number | CBZR0304 |
| Lot Number | 142562 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2015-06-05 |