MAUDE Adverse Event Report: ZIMVIE US CORP LLC TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 4.5MM(P) 5MM(H); DENTAL ABUTMENT

Catalog Number	TEEHA445
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient suffered from inflammation and disocclusion of the healing abutment for 1 month after placement.27 feb 2026 clarification: doctor indicated that disocclusion meaning loosening of the abutment.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) teeha445, (tsv® bellatek® encode® emergence healing abutment 4.5mm(d) 4.5mm(p) 5mm(h)) for evaluation.Visual evaluation and a functional test were performed, the abutment has signs of use, with marking from use and removal.The abutment screw threaded into the returned implant (tsvwb8) as intended.Unable to confirm loosening with all the available information.Measurements match drawing.Dhr review was completed for the subject lot number 1289212.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 1289212 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: functional: loosening¿.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was the screw wasn¿t torqued to specification.Therefore, based on the available information, a device malfunction could not be verified.The screw threaded into in-house implant as intended.The reported loosening 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 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: TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.5MM(D) 4.5MM(P) 5MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 24574192
• Report Number: 0001038806-2026-01292
• Device Sequence Number: 21121641
• Product Code: NHA
• UDI-Device Identifier: 00844868045823
• UDI-Public: (01)00844868045823(17)291008(10)1289212
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/27/2026

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: Other
• Device Catalogue Number: TEEHA445
• Device Lot Number: 1289212
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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 Age: 63 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic