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 Codes	Fracture (1260); Failure to Eject (4010)
Health Effect - Clinical Codes	Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.B3: date of event unknown / not provided.E1: last name unknown / not provided.G4: additional pma/510(k) number k011028, k013227.
Event or Problem Description
It was reported that the implant at tooth site #3 fractured and was removed.
Event or Problem Description
With fda.
Additional Manufacturer Narrative
Added 0001038806-2026-00224.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D2.Type of device.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H4: device manufacturer date.H10: additional narrative.This supplemental report is submitted per fda email request in order to submit product code dze.
Event or Problem Description
No further event information is available at the time of this report.

• 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: 24072532
• Report Number: 0001038806-2026-00226
• Device Sequence Number: 18443088
• Product Code: DZE
• UDI-Device Identifier: 00889024019379
• UDI-Public: (01)00889024019379(17)251111(10)1240988
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2021
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 03/02/2026

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 Expiration Date: 11/11/2025
• Device Catalogue Number: TSV6B10
• Device Lot Number: 1240988
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/12/2026
• 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; Not provided
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/11/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: DATA ADDED
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic