MAUDE Adverse Event Report: BIOMET 3I GOLD-TITE® HEXED UNISCREW; ABUTMENT SCREW

Catalog Number UNISG

Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528)

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

Event Date 03/23/2015

Event Type  Injury  

Event Description

The dentist reported the patient presented with a broken crown.During the oral examination, it was found that the abutment screw had fractured.The dentist was unable to retrieve the screw fragment from the implant and the implant had to be removed.

Manufacturer Narrative

The complaint investigator¿s visual inspection of returned components has confirmed a fragment of the abutment screw is inside of the implant.The investigator was unable to retrieve the screw fragment.No lot number for the screw was provided, therefore the device history record and complaint history reviews could not be completed.No definitive root cause could be determined.

• Brand Name: GOLD-TITE® 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: 4802086
• MDR Text Key: 5927539
• Report Number: 0001038806-2015-00685
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK072642
• 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
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNISG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OSS511
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR