MAUDE Adverse Event Report: ZimVie US Corp LLC BELLATEK® ABUTMENT TSV 4.5MM; Dental Abutment

Catalog Number	TSVLDAT4
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Difficulty Chewing (4522)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient presented with implant crown in hand, reports it came out two days ago.Exam revealed fractured hex off of bellatek custom abutment and fractured prosthetic screw.Remaining portion of screw in pt¿s #30 site along with fractured portion of custom abutment hex.Remaining portion of fractured device removed under local anesthesia and tissue punch to remove gingival overgrowth.Placed teeha465 encode for healing.Patientt unable to fully masticate on a right side.Abutment placed on (b)(6) 2024 and removed on (b)(6) 2026.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: premarket identification pma/510(k) #: k143505.

• Brand Name: BELLATEK® ABUTMENT TSV 4.5MM
• 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 ; +1(561)971-3230
• MDR Report Key: 50948112
• Report Number: 0001038806-2026-04981
• Device Sequence Number: 10348747
• Product Code: NHA
• UDI-Device Identifier: 00844868038092
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K071439
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Lay User/Patient
• Device Catalogue Number: TSVLDAT4
• Device Lot Number: 8989232-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2025
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 180 LB