MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SCR-V SBM 6M M 5.7MM 10MM; DENTAL IMPLANT

Catalog Number	TSV6B10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided.G4: additional pma/510(k) number ¿ k011028|k013227.The device will not 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
It was reported that the implant at an unknown tooth site was cracked and required removal.The patient's general dentist confirmed that the implant was cracked via pa x-ray imaging.An additional appointment was required to replace the implant and the implant crown following an undisclosed time to allow the tooth site to heal.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: during product evaluation, additional information was provided that confirmed that this case is a duplicate of mfr 0001038806-2026-00082.As a result, the prior submissions for mfr-0001038806-2026-00133 submitted on january 8, 2026 is no longer considered a reportable event by zimvie and no further reports will be submitted.The following sections are being reported: b4: date of this report was updated, b5: description of event was updated, g3: date received by manufacturer was updated, g6: type of report was updated, h2: type of follow up was updated, h10: additional narrative/data was updated.
Event or Problem Description
During product evaluation, additional information was provided that confirmed that this case is a duplicate of mfr 0001038806-2026-00082.As a result, the prior submissions for mfr-0001038806-2026-00133 submitted on january 8, 2026 is no longer considered a reportable event by zimvie and no further reports will be submitted.

• Brand Name: IMPL TAPERED SCR-V SBM 6M M 5.7MM 10MM
• Common Device Name: DENTAL IMPLANT
• 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: 24012566
• Report Number: 0001038806-2026-00133
• Device Sequence Number: 13097189
• Product Code: DZE
• UDI-Device Identifier: 00889024019379
• UDI-Public: (01)00889024019379(17)270809(10)1257341
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: Other
• Device Catalogue Number: TSV6B10
• Device Lot Number: 1257341
• 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
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic