MAUDE Adverse Event Report: BIOMET 3I 3I INCISE ZR COPING SHADE 2; ZIRCONIA COPING

Catalog Number CBZR0102

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

Product code = elz.

Event Description

The lab technician reported that the zirconia coping fractured near the buccal margin area 18 months post restoration.

Manufacturer Narrative

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).

• Brand Name: 3I INCISE ZR COPING SHADE 2
• Type of Device: ZIRCONIA COPING
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 5289960
• MDR Text Key: 33857047
• Report Number: 0001038806-2015-00870
• Device Sequence Number: 1
• Product Code: ELZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CBZR0102
• Device Lot Number: 132742
• Other Device ID Number: (01)00844868022626(10)132742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1