MAUDE Adverse Event Report: ZimVie US Corp LLC IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM; Dental Implant

Catalog Number	TSVWH10
Medical Device Problem Codes	Fracture (1260); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant neck fractured after the transfer hex component became stuck.The fractured component was successfully removed, however, due to dense bone and mobility, it was not possible to engage the 1.25 mm hex driver.The implant could not be removed by standard methods, and implant removal and replacement is recommended.Procedure not completed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).E1: email address: unknown / not provided.G4: premarket identification pma/510(k) #: k011028|k013227.

• Brand Name: IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 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 ; +1(561)971-3230
• MDR Report Key: 50816722
• Report Number: 0001038806-2026-04829
• Device Sequence Number: 10648492
• Product Code: DZE
• UDI-Device Identifier: 00889024020092
• UDI-Public: (01)00889024020092(17)300619(10)1299158
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2026
• Device Explanted Year: 2026
• 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): 09/18/2026

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: TSVWH10
• Device Lot Number: 1299158
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 176 LB