MAUDE Adverse Event Report: BIOMET 3I; UNKNOWN GINGIHUE ABUTMENT

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

Product not returned to manufacturer.

Event Description

It was reported that patient came in to the dental office with a fractured unknown gingihue abutment, and it cut the patient's tongue.

Manufacturer Narrative

The abutment returned was inspected and the fractured condition was confirmed.Visual inspection of the as received product identified that the abutment had fractured across the post.The coronal part of the fractured abutment remained in the crown.The bottom portion of the abutments appeared to be stripped, most likely due to a trephine burr.There was noticeable wear from use around the abutment hex and quick seat feature.The lot number for the abutment was not provided and therefore a device history record review could not be completed.A definitive root cause has not been determined.

• Type of Device: UNKNOWN GINGIHUE ABUTMENT
• 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: 6409351
• MDR Text Key: 70092849
• Report Number: 0001038806-2017-00090
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention