MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-18 for 3I INCISE ZR COPING SHADE 1 CBZR0101 manufactured by Biomet 3i.
[36632936]
Product code elz. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[36632937]
Zirconia coping fracture in two pieces.
Patient Sequence No: 1, Text Type: D, B5
[42543894]
The product did not return for evaluation, therefore the complaint could not be verified. The device history record review for the incise coping found no manufacturing deviations which would result in or contribute to this complaint. A definitive root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001038806-2016-00009 |
| MDR Report Key | 5375302 |
| Date Received | 2016-01-18 |
| Date of Report | 2015-12-21 |
| Date Mfgr Received | 2016-04-13 |
| Date Added to Maude | 2016-01-18 |
| 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 |
| 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 | 3 |
| Brand Name | 3I INCISE ZR COPING SHADE 1 |
| Generic Name | ZIRCONIA COPING |
| Product Code | NSP |
| Date Received | 2016-01-18 |
| Catalog Number | CBZR0101 |
| Lot Number | 144379 |
| ID Number | (01)00844868022619(17)150204(1 |
| 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 | 2016-01-18 |