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

Catalog Number CBZR0102

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

It was reported that the incisal edge on the incise coping has fractured.

Manufacturer Narrative

Coping not returned to manufacturer.Device not returned to manufacturer.

Manufacturer Narrative

There were no pictures of the reported fracture provided by the complainant, however, a customer designed rendering was provided.No lot number was provided.There were no manufacturing deviations identified which would result in or contribute to this complaint.Since no product or supporting information was provided this complaint cannot be verified.The device complaint or problem cannot be confirmed.(b)(4).

• Brand Name: 3I INCISE ZR COPING SHADE 2
• Type of Device: ZICONIA 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: 4584297
• MDR Text Key: 18266001
• Report Number: 0001038806-2015-00331
• 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: 02/17/2015

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: Other Health Care Professional
• Device Catalogue Number: CBZR0102
• Device Lot Number: 144364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 03/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1