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

Catalog Number	IEEHA443
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).A4: patient weight is not provided / unknown.E1: initial reporter¿s title is not provided / unknown.
Event or Problem Description
It was reported that they were unable to get healing abutment seated at uncovery.No bone or tissue were binding & preventing the seating another healing abutment was placed.
Additional Manufacturer Narrative
Zimvie complaint (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 and h10: additional narrative.Zimvie received one (1) ieeha443, (certain® bellatek® encode® emergence healing abutment 4.1mm(d) 4.1mm(p) 3mm(h)) for evaluation.Visual evaluation of the as returned device identified the abutment with signs of use.The abutment's packaging was not returned for evaluation.Additionally, functional testing with an in-house implant verified the abutment seated as intended.Dhr review was completed for the subject lot number 1275528.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 1275528 for similar events and no other complaint was identified.Review completed utilizing keywords: does not seat.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, and functional testing the abutment malfunction did not occur.The reported event/coob was non-verifiable since the condition of the product/packaging received by the customer was unknown / non-verifiable.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: CERTAIN BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 4.1MM(D) 4.1MM(P) 3MM(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: 19965873
• Report Number: 0001038806-2024-01757
• Device Sequence Number: 8962573
• Product Code: NHA
• UDI-Device Identifier: 00844868045458
• UDI-Public: (01)00844868045458(17)281204(10)1275528
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K212730
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: Health Professional
• Device Catalogue Number: IEEHA443
• Device Lot Number: 1275528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2024
• 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: 08/12/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2023
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic