MAUDE Adverse Event Report: ZIMMER DENTAL CERTAIN BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 4.1MM(D) 4.1MM(P) 3MM(H); DENTAL 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	07/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: weight unknown / not provided d10: t3st411, t3 pro non-platform switched tapered implant 4mm (d) x 11.5mm (l)/lot# 2022120058.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the healing abutment did not seat properly on the implant.The doctor placed an implant at tooth site #13.Then tried to place a healing abutment, but confirmed via peri-apical that it was not completely seated.As the doctor tried to back the healing abutment out, the implant backed out with it.The healing abutment appears to be "cold welded" to the implant as the doctor was not able to remove the healing abutment from the implant.A new implant was placed.
Event or Problem Description
No additional event information received at the time of this report.
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.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: 4109, 4111 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4315.H10: narrative/data was updated.Zimvie did not receive one the reported abutment for evaluation.Visual inspection could not be performed.The investigation has been performed based on all available information, complaint history review (chr), and the risk management file (rmf).Dhr review was completed for the subject lot number 1258219.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 1258219 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was the improper placing of screw or the abutments internal connection (abutment-implant interface) anti-rotational feature is designed too wide or the clinician selects incorrect abutment size.Please note, a definitive root cause could not be determined because the device was not returned.Therefore, based on the available information, device malfunction was not established.Without device receipt, the reported event was non-verifiable, since the condition of the product/packaging when received by 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 products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: CERTAIN BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 4.1MM(D) 4.1MM(P) 3MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 17445662
• Report Number: 0001038806-2023-01453
• Device Sequence Number: 2905716
• Product Code: NHA
• UDI-Device Identifier: 00844868045458
• UDI-Public: (01)00844868045458(17)271002(10)1258219
• 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
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/30/2024

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: IEEHA443
• Device Lot Number: 1258219
• Was Device Available for Evaluation?: No
• 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: 08/02/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2022
• 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: DENTAL IMPLANT.
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic