MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-12 for 3I INCISE ZR 6 UNIT FRAMEWORK SHADE 0 CBZR0600 manufactured by Biomet 3i.
[15126501]
It was reported that the zirconia coping bridge has fractured after it was placed in the patients mouth.
Patient Sequence No: 1, Text Type: D, B5
[15378971]
The reported fracture of the 3i incise zr 6 unit framework shade 0 could not be verified, product wasn't returned. There were no manufacturing deviations identified which would cause or contribute to the reported complaint. The dhr was reviewed, there were no manufacturing deviations identified which would result in or contribute to this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001038806-2015-00431 |
| MDR Report Key | 4593226 |
| Report Source | 05 |
| Date Received | 2015-03-12 |
| Date of Report | 2015-02-10 |
| Date Mfgr Received | 2015-02-10 |
| Device Manufacturer Date | 2015-02-13 |
| Date Added to Maude | 2015-04-15 |
| 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 | 0 |
| 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 6 UNIT FRAMEWORK SHADE 0 |
| Generic Name | ZIRCONIA COPING |
| Product Code | ELZ |
| Date Received | 2015-03-12 |
| Catalog Number | CBZR0600 |
| Lot Number | 143222 |
| Operator | LAY USER/PATIENT |
| 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 | 2015-03-12 |