MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-11 for 3I INCISE ZR COPING SHADE 2 CBZR0102 manufactured by Biomet 3i.
[33857047]
Product code = elz.
Patient Sequence No: 1, Text Type: N, H10
[33857048]
The lab technician reported that the zirconia coping fractured near the buccal margin area 18 months post restoration.
Patient Sequence No: 1, Text Type: D, B5
[38046219]
The component was returned and visual inspection confirmed that the device had fractured. Although an order number had been provided, the associated lot number and dhr information cannot be verified as psp-incise products are no longer manufactured at zimmer biomet. A definitive root cause could not be verified. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001038806-2015-00870 |
| MDR Report Key | 5289960 |
| Date Received | 2015-12-11 |
| Date of Report | 2015-11-16 |
| Date of Event | 2015-11-16 |
| Date Mfgr Received | 2016-02-04 |
| Date Added to Maude | 2015-12-11 |
| 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 COPING SHADE 2 |
| Generic Name | ZIRCONIA COPING |
| Product Code | ELZ |
| Date Received | 2015-12-11 |
| Returned To Mfg | 2015-11-19 |
| Catalog Number | CBZR0102 |
| Lot Number | 132742 |
| ID Number | (01)00844868022626(10)132742 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2015-12-11 |