MAUDE Adverse Event Report: BIOMET 3I; Abutment, implant, dental, endosseous

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2023

Event Type  malfunction  

Event Description

Doctor reported screw fracture at tooth site 36.On (b)(6) 2017 implant bost3210 with lot number 2016120867 was implanted (see x-ray attached).On 22 mar 2021 check up (see x-ray attached).On 20 mar 2023 implant crown was loose, abutment screw fractured (see x-ray attached).On 03 apr 2023 fractured screw was removed and a new one was placed.(capture under (b)(4).On 20 nov 2023 abutment screw fractured again (see picture attached) and it could not be removed with special set.Doctor confirmed to zv switzerland by phone that as of now, the implant remains in patient's mouth.

Manufacturer Narrative

Zimvie complaint number (b)(4).Since the lot number and device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received which indicated that the device may have caused or contributed to the event, an additional report would be submitted.H3 other text : product not returned.

• Type of Device: Abutment, implant, dental, endosseous
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18609326
• MDR Text Key: 334287233
• Report Number: 0001038806-2024-00148
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Exemption Number: 5645646
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic