MAUDE Adverse Event Report: BIOMET 3I BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H); DENTAL ABUTMENT

Catalog Number	EHA344
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).B3: date of event unknown / not provided; d4: additional device information unknown / not provided; d10.Concomitant medical products eha344, bellatek encode healing abutment 3.4mm(d) x; 3.8mm(p) x 4mm(h) lot 1239056.Therapy date: unknown.H4: device manufacturer date unknown / not provided.
Event or Problem Description
The doctor reports that the 2 healing abutments had damaged threads.Procedure completed.No implant on patient's health.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report, b5: describe event or problem, d4: additional device information, g3: date received by manufacturer, g6: type of report, h1: type of reportable event, h2: follow up type, h3: device evaluated by manufacturer, h4: device manufacturer date, h6: adverse event problem, h10: additional narrative.Zimvie received one (1) eha344, (bellatek encode healing abutment 3.4mm(d) x 3.8mm(p) x 4mm(h)) for evaluation.Visual evaluation was performed, the abutment has signs of use.The abutment's threads were bent and damaged.Device history record (dhr) review was completed for the subject lot number 1239056.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 1239056 for similar events and 1 other relevant complaint(s) was identified.Review completed utilizing keywords: dental: functional: damaged threads.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error and the torque applied during placement/seating exceeded recommended value.Therefore, based on the available information, a device malfunction did occur.The abutments threads were damaged from use.The reported event 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: BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(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: 21545086
• Report Number: 0001038806-2025-00478
• Device Sequence Number: 15217569
• Product Code: NHA
• UDI-Device Identifier: 00844868002840
• UDI-Public: (01)00844868002840(17)250908(10)1239056
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072642
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: Lay User/Patient
• Device Expiration Date: 09/08/2025
• Device Catalogue Number: EHA344
• Device Lot Number: 1239056
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT SEE H10 NARRATIVE.
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic