MAUDE Adverse Event Report: BIOMET 3I T3 TAPERED IMPLANT 6X10

Catalog Number BOST610

Device Problems Fracture (1260); No Apparent Adverse Event (3189)

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

Event Date 01/15/2016

Event Type  malfunction  

Event Description

The dentist reported the abutment screw fractured after 12-18 months in function.

Manufacturer Narrative

Additional information: updated information from the customer has determined that the screw did not break as originally reported.The implant has stripped internally from an unknown cause.The implant remains implanted.Correction: (b)(4).

Event Description

Implant was stripped by an unknown cause.The screw has not broke.

Manufacturer Narrative

The product associated with this complaint was not returned.The complaint could not be verified.The device history record review for the implant was performed and did not identify any non-conformances.A definitive root cause has not been determined.

• Brand Name: T3 TAPERED IMPLANT 6X10
• Type of Device: IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I DENTAL IBERICA SL; c/islas baleares, 50; pol. ind. fuente del jarro; paterna, valencia FL 33410
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 5703523
• MDR Text Key: 46856770
• Report Number: 0001038806-2016-00130
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK122300
• 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: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2018
• Device Catalogue Number: BOST610
• Device Lot Number: 2013080307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2013
• 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 Age: 69 YR