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

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

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

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

The implant was returned on june 14, 2016.

Event Description

The dentist reported the patient was released for final restoration and the general dentist broke the screw off in the implant.The dentist was unable to retrieve the broken piece, therefore, the implant was removed and bone graft placed.

Manufacturer Narrative

One implant has been returned for review.Evidence of a stuck component was identified within the implant.The fractured portion has not been provided for review.Outside of general evidence of usage, the returned implant does not appear damaged.Visual comparison of the implant to the drawing did not provide indication of a manufacturing deviation.The item number or lot number for the screw was not provided and therefore a device history record review could not be completed.The device history record review for the implant lot was performed and did not identify any manufacturing deviations that would contribute to this event.A definitive root cause has not been determined.

• Brand Name: UNKNOWN SCREW
• Type of Device: ABUTMENT SCREW
• 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: 5789947
• MDR Text Key: 49399149
• Report Number: 0001038806-2016-00161
• Device Sequence Number: 1
• Product Code: DZE
• 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
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR