MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.1MM(D) 5MM(P) 5MM(H); DENTAL ABUTMENT

Catalog Number	IEEHA455
Medical Device Problem Codes	Mechanical Problem (1384); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).A4: weight unknown / not provided d10: (b)(6), osseotite tapered certain prevail implant 5/4 x 13mm / lot number: (b)(6).It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that while trying to drill it the abutment, the internal threads of the implant were damaged in the process.Due to the hex of the healing abutment being stripped, the implant had to be removed.Symptoms as a result of the event: pain.
Event or Problem Description
Contacted oral surgeon for additional details.It was reported that the top hex of the encode healing abutment was stripped.While trying to drill it the abutment, the internal threads of the implant were damaged in the process.The implant was removed and site grafted.Patient will return later to replace.Symptoms as a result of the event: pain.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie did not receive one (1) ieeha455, (certain® bellatek® encode® emergence healing abutment 4.1mm(d) 5mm(p) 5mm(h)) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Dhr review was completed for the subject lot number 1266604.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 1266604 for similar events and no other complaint was identified.Review completed utilizing keywords: damaged drive feature.Based on the investigation and risk management file review, the most likely root cause determined from the investigation is incorrect techniques used - customer error.Therefore, based on the available information, a device malfunction could not be verified.Without device receipt, 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.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 4.1MM(D) 5MM(P) 5MM(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: 21277252
• Report Number: 0001038806-2025-00230
• Device Sequence Number: 3664412
• Product Code: NHA
• UDI-Device Identifier: 00844868045496
• UDI-Public: (01)00844868045496(17)280425(10)1266604
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K212730
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 05/28/2025

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: IEEHA455
• Device Lot Number: 1266604
• Was Device Available for Evaluation?: No
• 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: 01/30/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2023
• 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 / SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic