MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 11.5MM; TAPERED IMPLANT

Catalog Number INT3211

Device Problems Inadequacy of Device Shape and/or Size (1583); Packaging Problem (3007); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Manufacturer Narrative

Remains implanted.

Event Description

The doctor reported that he was going to place a int3211 (lot 2015060463) and inside the box was a int411.The site had enough bone so he placed the 4mm implant.

Manufacturer Narrative

The reported incorrect product packaged could not be verified as product associated with this event has not been provided for review.A review of the provided radiographs was inconclusive due to poor resolution quality.The device history record review, the non-conformance history review, and the etq complaint history review did not provide an indication of a manufacturing deviation.The review of scrap part labels and supporting production logs for a consecutive run of int3211 and int411 was completed for a potential lot mix-up, and no anomalies were identified.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 11.5MM
• Type of Device: TAPERED 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: 5438384
• MDR Text Key: 38299560
• Report Number: 0001038806-2016-00015
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: PK063341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: INT3211
• Device Lot Number: 2015060463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• 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 Age: 47 YR