MAUDE Adverse Event Report: BIOMET 3I NAVIGATOR® CERTAIN® IMPLANT MOUNT, 4.1MM(D) X 2(L); IMPLANT MOUNT SCREW

Catalog Number SGIIM42

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

Patient Problems No Information (3190); No Code Available (3191)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

Product requested but not yet returned.

Event Description

The dentist reported that during implant placement the mount screw fractured off inside the implant.The implant was surgically removed 1 week later and another implant was placed during the same procedure.

Manufacturer Narrative

Returned to manufacturer box checked, added product return date added aware date.Correction and additional information boxes checked.

Manufacturer Narrative

The returned item was visually inspected.Evidence of the fractured implant mount was observed inside the implant.The lot number for the mount screw was not provided and therefore a device history record review could not be completed.The device history record review for the implant was performed and did not identify any non-conformances.

• Brand Name: NAVIGATOR® CERTAIN® IMPLANT MOUNT, 4.1MM(D) X 2(L)
• Type of Device: IMPLANT MOUNT 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: 5996236
• MDR Text Key: 56360356
• Report Number: 0001038806-2016-00249
• 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,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: SGIIM42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: IFOS485
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR