MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP,TSV,3.7,13,MTX,MG; DENTAL IMPLANT

Catalog Number	TSVTB13
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown/not provided.A2: age at time of the event unknown/not provided.A4: patient weight unknown/not provided.
Event or Problem Description
It was reported the green top of the inner tube was broken, dentist did not use it because the implant was no longer sterile.Procedure was completed with another implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report, b5: describe event or problem, d9: device availability updated to no, d10.Concomitant medical products.Ct3113, eztetic dental implant, 3.1mm diameter, 2.9mmd platform, 13mm length, lot number unknown.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 made multiple follow up attempts to obtain additional information regarding the returned ct3113.However, no further details have been received.No damage was found with the returned ct3113.The reported device was recorded as not returned and the ct3113 device was recorded as a concomitant medial device.Zimvie did not receive one (1) tsvtb13, (imp, tsv,3.7,13, mtx, mg) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number 1293481.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 1293481 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿packaging: inner sterile package opened¿ based on the investigation and risk management file review, the most likely root cause determined was improper handling of product outside of zimvie¿s controls.Therefore, based on the available information, a packaging malfunction was not established.No images were submitted.Without device receipt, the reported event/coob is non-verifiable since the condition of the product/packaging received by the customer was unknown.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.

• Brand Name: IMP,TSV,3.7,13,MTX,MG
• 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: 24330950
• Report Number: 0001038806-2026-00722
• Device Sequence Number: 9799422
• Product Code: DZE
• UDI-Device Identifier: 00889024019942
• UDI-Public: (01)00889024019942(17)291124(10)1293481
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K101977
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: TSVTB13
• Device Lot Number: 1293481
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/10/2026
• 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: 02/13/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT SEE H10 NARRATIVE.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic