MAUDE Adverse Event Report: ZIMMER DENTAL TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 4.5MM(D) 5.5MM(P) 3MM(H); DENTAL ABUTMENT

Catalog Number	TEEHA453
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
Zimmer biomet complaint number (b)(4).A1: patient identifier unknown / not provided.A2: age and date of birth unknown / not provided.A3: patient sex unknown / not provided.A4: weight unknown / not provided.B3: date of event unknown / not provided.D10: tsvmwb10, imp,tsv,mcol mg,4.7mm,10m/lot number- 1252288.D10: therapy date unknown / not provided.It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
The sales rep indicated that the healing abutment encode is not fully seated.It looks like it is stuck to the implant.Tooth #18.The doctor was not able to complete the procedure and sent the patient home.
Event or Problem Description
Upon follow up, it was reported that the procedure was completed with another abutment.The screw fractured during the removal of the healing abutment.Not prior.Also, the final restorative abutment seated correctly and the patient is fine.
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: h6: type of investigation codes were added: 4109, 4111, 4114 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4315.Zimvie did not receive the reported healing abutment for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number 1257002.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 1257002 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 were missing or confusing instructions for use and torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, device malfunction could not be verified.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: TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 4.5MM(D) 5.5MM(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: 17737743
• Report Number: 0002023141-2023-02527
• Device Sequence Number: 17826644
• Product Code: NHA
• UDI-Device Identifier: 00844868045847
• UDI-Public: (01)00844868045847(17)270815(10)1257002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2024

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: TEEHA453
• Device Lot Number: 1257002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 09/25/2023; 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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-SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic