MAUDE Adverse Event Report: BIOMET 3I CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H); DENTAL ABUTMENT

Catalog Number	IEHA444
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient always felt uncomfortable with the implant at tooth location #3.The dentist placed a healing abutment and the screw wasn't tightening.The dentist recommended removal because the implant was loose.The implant was removed due to the healing abutment not seating.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10: xiitp5485, osseotite tapered certain prevail implant 5/4 x 8.5mm/lot# 2022011159.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4315.H10: narrative/data was updated.Zimvie received the reported abutment for evaluation.However, the device was unable to be located.Upon locating the device, this investigation will be reopened and updated accordingly.The investigation has been completed based on the available device information and complaint history review.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 user error.Therefore, based on the available information, device malfunction could not be verified.The reported event is non-verifiable.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 event information received at the time of this report.

• Brand Name: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H)
• Common Device Name: DENTAL 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: 21635068
• Report Number: 0001038806-2025-00622
• Device Sequence Number: 13093542
• Product Code: NHA
• UDI-Device Identifier: 00844868004608
• UDI-Public: (01)00844868004608(17)281114(10)1274563
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: IEHA444
• Device Lot Number: 1274563
• 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: 03/18/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic