MAUDE Adverse Event Report: BIOMET 3I TITANIUM HEXED UNISCREW; ABUTMENT SCREW

Catalog Number IUNIHT

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/02/2015

Event Type  Injury  

Manufacturer Narrative

Two implants were returned together.The implants were visually inspected together as they could not be distinguished.There was some damage noted to the exterior of the implants, as well as evidence of remnant bone.There was evidence of a fractured screw in the bottom of both implants.The remainder of the screw(s) were not returned.The device history record for the screw could not be reviewed as no lot number was provided.However, the device history record for the implant was reviewed and did not identify any manufacturing deviations which would result in or contribute to this complaint.A definitive root cause has not been determined.Discarded.

Event Description

The dentist reported the screw fractured inside the implant.The dentist was unable to remove the screw so the implant was removed.

• Brand Name: TITANIUM HEXED UNISCREW
• Type of Device: ABUTMENT 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: 5126945
• MDR Text Key: 27445305
• Report Number: 0001038806-2015-00801
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IUNIHT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR