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

Catalog Number	IEEHA355
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Implant placement at tooth site #13 was reported.An implant and also the healing abutment was placed that day.Clinician could not separate the abutment from the implant, until the implant was removed from the osteotomy, and when the clinician had seated the abutment, it had caused the implant to spin.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).A4: patient weight is not provided / unknown.D10: dental implant, 3i t3 tapered implant 4/3 x 13mm, lot number 2022060896.
Additional Manufacturer Narrative
This report is being submitted to report additional information.Zimvie received one healing abutment for evaluation.Visual evaluation of the as returned device identified the abutment with signs of use.The abutment engaged and disengaged as intended from the implant, during a functional test.Dhr review was completed for the subject lot number.No deviations or non-conformances, which could have caused or contributed to the reported events, 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.A definitive root cause could not be determined since the device malfunction did not occur, and the reported events have been unconfirmed following functional testing and physical evaluation.Therefore, based on the available information, and functional testing a device malfunction did not occur.The reported events were unconfirmed with all the available information.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 or corrected information to report.

• Brand Name: CERTAIN BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 3.4MM(D) 5MM(P) 5MM(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: 19559024
• Report Number: 0001038806-2024-01258
• Device Sequence Number: 4850691
• Product Code: NHA
• UDI-Device Identifier: 00844868045434
• UDI-Public: (01)00844868045434(17)290205(10)1275881
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: IEEHA355
• Device Lot Number: 1275881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2024
• 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: 06/18/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BOPT4313
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic