MAUDE Adverse Event Report: BIOMET 3I TSV BELLATEK ENCODE HEALING ABUTMENT 4.5MM (D) X 5.0MM (P) X 5MM (H); DENTAL HEALING ABUTMENT

Catalog Number	TEHA4505
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Multiple reports are being submitted for this event.
Event or Problem Description
It was reported that implant in tooth site #14 had a mobile crown and upon removal, the abutment screw was fractured and the implant was fractured as well.Symptoms as a result of the event: inflammation.
Additional Manufacturer Narrative
This report is being submitted to report additional information.Multiple reports are being submitted for this event.The following sections are being reported: d4: expiration date and unique identifier (udi) number.D9: device availability.H2: if follow-up, what type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: type of investigation.H6: investigation findings.H6: investigation conclusions.H10: additional narratives/data.Zimvie received partial of one healing abutment for evaluation.Visual evaluation was performed, bottom portion of the abutment, screw threads, is fractured of into the implant.Dhr review was completed for the subject lot number.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was material selection of the product is not adequate to withstand occlusal forces therefore, based on the available information, a device malfunction did occur.The abutment screw threads was found fractured inside the returned implant.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: TSV BELLATEK ENCODE HEALING ABUTMENT 4.5MM (D) X 5.0MM (P) X 5MM (H)
• Common Device Name: DENTAL HEALING ABUTMENT
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18870618
• Report Number: 0001038806-2024-00416
• Device Sequence Number: 14205515
• Product Code: NHA
• UDI-Device Identifier: 00844868040958
• UDI-Public: (01)00844868040958(17)260321(10)1243181
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173374
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/20/2026
• Device Catalogue Number: TEHA4505
• Device Lot Number: 1243181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic