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

Catalog Number	IMHA34
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
The doctor reports that the healing abutments are not seating correctly on the implant.The procedure was concluded with the placement of other abutments with no impact on the patient's health.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10: concomitant medical products: imha34, certain¿ ep¿ healing abutment 3.4mm(d) x 3.8mm(p) x 4mm(h), 1190410 imha34, certain¿ ep¿ healing abutment 3.4mm(d) x 3.8mm(p) x 4mm(h), 1190410 d10: therapy date: unknown / not provided.
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 g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative.Zimvie received one (1) imha34, (certain ep healing abutment 3.4mm(d) x 3.8mm(p) x 4mm(h)) for evaluation.Visual evaluation and a functional test were performed, the returned abutment has signs of use and was identified as reported.The abutment's screw threads were damaged from use.Therefore, the abutment did not seat as intended during a functional test with an in-house implant.Device history record (dhr) review was completed for the subject lot number 1190410.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 1190410 for similar events and other relevant complaint(s) were identified.Review completed utilizing keywords: dental : fit : does not seat.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error.Therefore, based on the available information, a device malfunction did occur.The abutments threading was damaged from use.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¿ EP¿ HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(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: 21112226
• Report Number: 0001038806-2025-00069
• Device Sequence Number: 20717562
• Product Code: NHA
• UDI-Device Identifier: 00844868006275
• UDI-Public: (01)00844868006275(17)201201(10)1190410
• 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): 03/26/2025

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: 12/01/2020
• Device Catalogue Number: IMHA34
• Device Lot Number: 1190410
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/20/2024
• 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: 01/09/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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 HEALING ABUTMENTS.
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic