MAUDE Adverse Event Report: BIOMET 3I BELLATEK¿ ENCODE¿ HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 6MM(H); DENTAL HEALING ABUTMENT

Catalog Number	EHA556
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that the abutment does not screw into the implant.Proceeding wasn't completed with the healing abutment.No impact on the patient reported.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D3.Manufacturer email address.G1.Contact office name and email address.G1.Contact office - manufacturer site - email address.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) eha556, (bellatek encode healing abutment 5mm(d) x 5.6mm(p) x 6mm(h)) for evaluation.Visual evaluation was performed, the returned abutment has signs of use.The retaining screw had signs of use with debris on its threading.The abutment matched drawing.The abutment seated, engaged and disengaged with an in-house implant as intended.Dhr review was completed for the subject lot number 1267302.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 1267302 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : fit : does not seat¿ a definitive root cause could not be determined since a device malfunction did not occur.The reported event was unconfirmed following functional testing and physical evaluation.Therefore, based on the available information, a device malfunction did not occur.The abutment engaged and disengaged with an in-house implant as intended.The reported abutment assembling event was unconfirmed.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: BELLATEK¿ ENCODE¿ HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 6MM(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: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23051819
• Report Number: 0001038806-2025-02155
• Device Sequence Number: 9741312
• Product Code: NHA
• UDI-Device Identifier: 00844868003090
• UDI-Public: (01)00844868003090(17)280626(10)1267302
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2025

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: Other
• Device Catalogue Number: EHA556
• Device Lot Number: 1267302
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/21/2025
• 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: 09/15/2025
• Supplement Report FDA Received Date: 11/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic