MAUDE Adverse Event Report: BIOMET 3I NAVIGATOR® CERTAIN® IMPLANT MOUNT 3.4MM(D) SHORT

Catalog Number MSGIIMS

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260)

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

Event Date 12/14/2016

Event Type  malfunction  

Event Description

The dentist reported that while trying to remove the mount from the implant after having placed the implant, the mount broke off in the implant.The dentist removed the implant and placed another one from stock.

Manufacturer Narrative

Upon visual inspection, the implant mount had fractured and the fractured screw piece remained stuck in the implant.The complaint was confirmed.The lot number for implant mount was not provided and therefore a device history record review could not be completed.A definitive root cause has not been determined.

• Brand Name: NAVIGATOR® CERTAIN® IMPLANT MOUNT 3.4MM(D) SHORT
• Type of Device: IMPLANT MOUNT
• 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: 6230728
• MDR Text Key: 64508509
• Report Number: 0001038806-2017-00005
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: MSGIIMS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Age: 39 YR