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

Catalog Number CBZR0103

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the zirconia coping fractured during placement.

Manufacturer Narrative

Visual evaluation of the returned coping confirmed that it had fractured.Through the investigation of this complaint, a definitive root cause could not be determined.There were no manufacturing deviations which may have contributed to the reported fracture.

Manufacturer Narrative

Added device manufacture date.

• Brand Name: 3I INCISE ZR COPING SHADE 3
• 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: 4483181
• MDR Text Key: 16304285
• Report Number: 0001038806-2015-00060
• Device Sequence Number: 1
• Product Code: ELZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2015

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: CBZR0103
• Device Lot Number: 143439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2015
• Initial Date FDA Received: 02/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1