MAUDE Adverse Event Report: BIOMET 3I BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H); DENTAL ABUTMENT

Catalog Number	EHA554
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age and date of birth unknown / not provided.A3: patient sex unknown / not provided.A4: weight unknown / not provided.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.
Event or Problem Description
It was reported that after implanting the implant, we attempted to fit the encode healing abutment for the first time, but it would not seat and floated.The sales representative brought two (2) loaner implants to the clinic and attempted to fit the healing abutment, but it similarly floated and could not be fitted.A replacement healing abutment is scheduled for use shortly.
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: 10, 4109, 4111 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 67 and 4315.H10: narrative/data was updated.Zimvie received the reported healing abutment for evaluation.Visual evaluation and functional test were performed.The returned encode healing abutment has signs of use, and was returned along with its bundle screw.The encode healing abutment was observed outside of its original packaging.The packaging was not returned for evaluation.During a functional / physical test with an in-house biomet short implant (external hex), the encode healing abutment seated as intended.Returned encode healing abutment matched prints where measured.The reported event is non-verifiable as the conditions of the product / packaging delivered to the customer are unknown / non-verifiable.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.The customer did submit an image for the reported event.A definitive root cause could not be determined since device malfunction did not occur.Therefore, based on the available information, device malfunction did not occur.During a functional / physical test with an in-house biomet short implant (external hex) the encode healing abutment seated as intended.The reported event is non-verifiable as the conditions of the product / packaging delivered to the customer are unknown / 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: BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(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: 23095321
• Report Number: 0001038806-2025-02200
• Device Sequence Number: 18334353
• Product Code: NHA
• UDI-Device Identifier: 00844868003083
• UDI-Public: (01)00844868003083(17)290320(10)1279454
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: EHA554
• Device Lot Number: 1279454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/19/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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 IMPLANT.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic