MAUDE Adverse Event Report: ZIMVIE US CORP LLC HEAL COLLAR 3.5X4.5, 7MM; DENTAL ABUTMENT

Catalog Number	HC347
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the restoration doctor attempted to remove the healing abutment and it was fused to the implant at tooth site #9.The general dentist attempted to remove the healing collar and was unable to do so.The patient was referred back to the surgeon for evaluation.The surgeon then had to apply a large amount of force to the healing collar and was unsuccessful at removing it prior to the implant breaking its integration and backing out.A new implant was placed.Symptoms as a result of the event: pain.

• Brand Name: HEAL COLLAR 3.5X4.5, 7MM
• 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: 25233648
• Report Number: 0001038806-2026-02821
• Device Sequence Number: 14722934
• Product Code: NHA
• UDI-Device Identifier: 00889024015012
• UDI-Public: (01)00889024015012(17)300726(10)2120036711
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K111852
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: HC347
• Device Lot Number: 2120036711
• 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
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2025
• 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: TSX41B11, TSX IMPLANT, 4.1MMD, 11.5MML.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic