MAUDE Adverse Event Report: BIOMET 3I T3 TAPERED IMPLANT 4X10

Catalog Number BOST410

Device Problems Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)

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

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

Remains implanted.

Event Description

The dentist reported implant fixture 4x10 was placed.After placing implant, an x-ray was taken and the implant appeared longer; measured and appeared to be 4x11.5.

Manufacturer Narrative

The product did not return for evaluation, but the customer provided x-rays.The x-rays show a measurement against the implant, but it is unknown the scale and the measurement tools used.Biomet 3i suggested to the doctor to do a ct scan, but he declined due to the cost.Therefore, this complaint cannot be verified.The device history record review for the implant lot was performed and did not identify any non-conformances.A definitive root cause has not been determined.(b)(4).

• Brand Name: T3 TAPERED IMPLANT 4X10
• 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
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 5651416
• MDR Text Key: 45958967
• Report Number: 0001038806-2016-00102
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK122300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 06/17/2020
• Device Catalogue Number: BOST410
• Device Lot Number: 2015060322
• Other Device ID Number: (01)00844868028925(17)200617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• 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