MAUDE Adverse Event Report: BIOMET 3I CERTAIN BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 3.4MM(D) 5MM(P) 7MM(H); DENTAL HEALING ABUTMENT

Catalog Number	IEEHA357
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).A2: patient age is not provided / unknown.A4: patient weight is not provided / unknown.E1: initial reporter¿s title is not provided / unknown.
Event or Problem Description
It was reported that the day before the operation, the doctor checked the product in advance.He confirmed that the screw got stuck and couldn't turn, but instead turned with the healing abutment.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Zimvie received one (1) ieeha357, (certain bellatek encode emergence healing abutment 3.4mm(d) 5mm(p) 7mm(h)) for evaluation.Visual evaluation/functional testing was performed, slight wear marking on screw and is stuck and not able to move inside abutment.Unable to remove.Malfunction has been identified.Dhr review was completed for the subject lot number 1266522.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 1266522 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : fit : other based on the investigation and risk management file review, the most likely root cause determined from the investigation was torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.The screw is stuck and not able to move inside abutment.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: CERTAIN BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 3.4MM(D) 5MM(P) 7MM(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: 20534897
• Report Number: 0001038806-2024-02424
• Device Sequence Number: 6682146
• Product Code: NHA
• UDI-Device Identifier: 00844868045441
• UDI-Public: (01)00844868045441(17)280422(10)1266522
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212730
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: IEEHA357
• Device Lot Number: 1266522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/25/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2023
• 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