MAUDE Adverse Event Report: ZIMMER DENTAL TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 3.5MM(D) 3.8MM(P) 3MM(H); DENTAL ABUTMENT

Catalog Number	TEEHA333
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the general practitioner was unable to seat the coping in the implant site #13 stating that the tissue kept collapsing.Unable to get good contour.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 67.H10: narrative/data was updated.Zimvie received the reported healing abutment for evaluation.Visual evaluation of the as returned device identified the abutment with signs of use, minor wear and was identified as reported.Abutment matched prints where measured.During a functional test with an in-house zimmer implant the abutment seated as intended.No apparent malfunction was identified.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product is within specifications.Complaint history review was performed for the reported lot number 1264358 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are missing or confusing labeling or the clinician placed a healing abutment and screw in a patient with patient factors incompatible with proper soft tissue healing (e.G.Poor patient hygiene, periodontal issues, preexisting medical conditions.) therefore, based on the available information, device malfunction did not occur.The reported event was non-verifiable 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.

• Brand Name: TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 3.5MM(D) 3.8MM(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: 17458044
• Report Number: 0001038806-2023-01461
• Device Sequence Number: 2584808
• Product Code: NHA
• UDI-Device Identifier: 00844868045724
• UDI-Public: (01)00844868045724(17)280219(10)1264358
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 01/25/2024

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: TEEHA333
• Device Lot Number: 1264358
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/10/2023
• 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: 08/04/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2023
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic