MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-10 for 3I INCISE ZR COPING SHADE 2 CBZR0102 manufactured by Biomet 3i.
[18266001]
It was reported that the incisal edge on the incise coping has fractured.
Patient Sequence No: 1, Text Type: D, B5
[18645561]
Coping not returned to manufacturer. Device not returned to manufacturer
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001038806-2015-00331 |
| MDR Report Key | 4584297 |
| Report Source | 05 |
| Date Received | 2015-03-10 |
| Date of Report | 2015-02-17 |
| Date Mfgr Received | 2015-03-17 |
| Device Manufacturer Date | 2015-02-02 |
| Date Added to Maude | 2015-04-06 |
| 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 2 |
| Generic Name | ZICONIA COPING |
| Product Code | ELZ |
| Date Received | 2015-03-10 |
| Catalog Number | CBZR0102 |
| Lot Number | 144364 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2015-03-10 |