MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-01 for 3I INCISE ZR 4 UNIT FRAMEWORK SHADE 5 CBZR0405 manufactured by Biomet 3i.
[37469080]
Device product code is elz. (code was not available in drop down list) device not returned.
Patient Sequence No: 1, Text Type: N, H10
[37469081]
The lab tech indicated that the zirconia coping (cbzr0405) fractured.
Patient Sequence No: 1, Text Type: D, B5
[40658647]
The device did not return; therefore no evaluation could be performed and complaint could not be confirmed. The lot number for the zirconia coping was not provided and therefore a device history record review could not be completed. A review of complaint trending did not provide indication of a manufacturing deviation. A definitive root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001038806-2016-00001 |
| MDR Report Key | 5402363 |
| Date Received | 2016-02-01 |
| Date of Report | 2016-01-07 |
| Date Mfgr Received | 2016-03-17 |
| Date Added to Maude | 2016-02-01 |
| 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 | 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 4 UNIT FRAMEWORK SHADE 5 |
| Generic Name | ZIRCONIA COPING |
| Product Code | NSP |
| Date Received | 2016-02-01 |
| Catalog Number | CBZR0405 |
| 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 | 2016-02-01 |