MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ BELLATEK¿ ENCODE¿ EMERGENCE HEALING ABUTMENT 3.4MM(D) 3.8MM(P) 5MM(H); DENTAL ABUTMENT

Catalog Number	IEEHA345
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
Doctor reported that the encode abutment does not seat into the implant.Procedure completed with other encode abutment.Tooth location 16.
Additional Manufacturer Narrative
Zimvie complaint number (b)(6).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) ieeha345, (certain bellatek encode emergence healing abutment 3.4mm(d) 3.8mm(p) 5mm(h) for evaluation.Visual evaluation and a functional test was performed, the abutment had signs of use.It was tested in-house implant and it engaged and dis engaged as intended.Device history record (dhr) review was completed for the subject lot number 1271244.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 1271244 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 with an in-house implant as intended.The reported event was not 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN¿ BELLATEK¿ ENCODE¿ EMERGENCE HEALING ABUTMENT 3.4MM(D) 3.8MM(P) 5MM(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: 20320261
• Report Number: 0001038806-2024-02192
• Device Sequence Number: 7678765
• Product Code: NHA
• UDI-Device Identifier: 00844868045403
• UDI-Public: (01)00844868045403(17)280822(10)1271244
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2024

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: IEEHA345
• Device Lot Number: 1271244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• 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: 09/27/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic