FDA Adverse Event
Malfunction
Summary report: N
3I INCISE ZR COPING SHADE 2
MDR report key: 5289960
·
Received December 11, 2015
Report
- Report Number
- 0001038806-2015-00870
- Event Type
- Malfunction
- Date Received
- December 11, 2015
- Date of Event
- November 16, 2015
- Report Date
- November 16, 2015
- Manufacturer
- BIOMET 3I
- Product Code
- ELZ
- PMA / PMN Number
- PEXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT CODE = ELZ.
Additional Manufacturer Narrative · 1
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)
Description of Event or Problem · 1
THE LAB TECHNICIAN REPORTED THAT THE ZIRCONIA COPING FRACTURED NEAR THE BUCCAL MARGIN AREA 18 MONTHS POST RESTORATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 820503 | 3I INCISE ZR COPING SHADE 2 | ZIRCONIA COPING | ELZ | BIOMET 3I | 132742 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |