MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM; DENTAL IMPLANT

Catalog Number	TSVH10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.G4: additional pma/510(k) number k011028, k013227.
Event or Problem Description
It was reported that implant was removed due to platform fracture.Prefer to reimplant + graft + membrane.
Additional Manufacturer Narrative
Zimvie received one (1) tsvh10, (impl tapered scr-v ha 3.7 mm 3.5mm 10mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent bone / tissue attached to external threads.The alleged implant fracture was not identified anywhere on the implant.However, a fractured screw fragment was observed stuck inside the implant.Implant matched prints where measured.Additionally, the returned implant was observed damaged around the external threads / collar regions; likely due to the removal process.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1238871.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 1238871 for similar events and no other complaint was identified.The customer did not submit images for the reported event.A definitive root cause could not be determined since the implant malfunction did not occur, and the reported event has been unconfirmed following visual and physical evaluation.Therefore, based on the available information, the implant malfunction did not occur.The reported event was unconfirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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.The following sections have been updated: b4: date of this report d9: device availability g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes h11: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 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: 23822097
• Report Number: 0001038806-2025-03890
• Device Sequence Number: 13108131
• Product Code: DZE
• UDI-Device Identifier: 00889024019560
• UDI-Public: (01)00889024019560(17)251007(10)1238871
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: 10/07/2025
• Device Catalogue Number: TSVH10
• Device Lot Number: 1238871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/16/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic