MAUDE Adverse Event Report: ZIMVIE US CORP LLC GENTEK® SCANBODY, CERTAIN®, 4.1MMD; DENTAL SCANBODY

Catalog Number	ZFX05Z-ZB-CE-41
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age at time of the event: unknown / not provided.A4: patient weight: unknown / not provided.D4: expiration date: unknown / not provided.
Event or Problem Description
It was reported that during the insertion of the scanbody, doctor was unable to unscrew it.Patient returned on (b)(6) 2025 to complete the procedure with other scanbody and the implant was not affected.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H11: additional narrative.Zimvie did not receive one (1) gentek® scanbody, certain®, 4.1mmd (zfx05z-zb-ce-41) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number review, and risk management file (rmf).Complaint history review was performed for the reported lot 2409050001 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿does not disengage¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was multiple used.Product is used more times as specified.Therefore, based on the available information, a device malfunction was not established.Without device receipt, the reported event is non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: GENTEK® SCANBODY, CERTAIN®, 4.1MMD
• Common Device Name: DENTAL SCANBODY
• 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: 24002128
• Report Number: 0001038806-2026-00109
• Device Sequence Number: 21378439
• Product Code: NDP
• UDI-Device Identifier: 04251881769029
• UDI-Public: (01)04251881769029(10)2409050001(240)ZFX05Z-ZB-CE-41
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: ZFX05Z-ZB-CE-41
• Device Lot Number: 2409050001
• Was Device Available for Evaluation?: No
• 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: 01/08/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2024
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic