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

Catalog Number	TEHA4503
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the encode abutment would not seat in the patients mouth.They were able to use another abutment to complete the case.
Additional Manufacturer Narrative
Zimvie complaint: (b)(4).A1: patient identifier is not provided / unknown.A2: patient age is not provided / unknown.A4: patient weight is not provided / unknown.B3: date of event is not provided / unknown.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The following sections are being reported: d4: expiration date and unique identifier (udi) number.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.One healing abutment was returned for investigation.Visual evaluation of the as returned product identified no malfunction.During a functional test the abutment seated on an in-house implant as intended.Dhr review for the lot had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot and no similar event or complaint was found.Based on the investigation and risk management file review, and ifu, the most likely root cause determined from the investigation was incorrect technique used during placement.Therefore, based on the available information, device malfunction did not occur.However, the reported event could not be verified.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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 3MM (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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 17458878
• Report Number: 0001038806-2023-01464
• Device Sequence Number: 2698324
• Product Code: NHA
• UDI-Device Identifier: 00844868040941
• UDI-Public: (01)00844868040941(17)261219(10)1251126
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2024

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: Health Professional
• Device Catalogue Number: TEHA4503
• Device Lot Number: 1251126
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2023
• 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: 08/04/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2021
• 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 Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic