MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM; DENTAL IMPLANT

Catalog Number	TSVB13
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: additional pma/510(k) number ¿ k011028|k013227.Product has been received by zimvie and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant that the customer received had the correct label on the box and the implant vial, but that the top sticker was labeled as a 4.1 x 8mm device, but that the implant was a 3.7 x 13mm device.This issue was discovered during a procedure.The device had been placed in the patient's mouth.The device was removed during the surgery procedure.The procedure was able to be completed with another implant.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation code was added: 10, 4109, 3331 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4315.H11: narrative/data was updated.Zimvie received the reported device for evaluation.Visual evaluation / functional test was performed, the implant was returned with no damage however not in its original sealed packaging.The outer vial cap was for a 4.1mm x 8mm implant, while 3.7 and 13 was handwritten on it.The implants outer vial tamper seal was broken.The implants measurements match drawing.Dhr review was completed for the subject lot number.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 for similar events and no other complaint was identified.The customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was improper handling of product outside of zimvie controls.Therefore, based on the available information, a device malfunction did not occur.The implant was returned, outside its original packaging, and measurements match drawing.Even though the cap label was returned different, the cap seal was broken.The reported event/coob could not be verified with all the available information.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.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
• 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: 24561476
• Report Number: 0001038806-2026-01275
• Device Sequence Number: 15812567
• Product Code: DZE
• UDI-Device Identifier: 00889024019522
• UDI-Public: (01)00889024019522(17)300130(10)1295386
• 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
• 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
• Report Date (Section B): 04/07/2026

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: TSVB13
• Device Lot Number: 1295386
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/24/2026
• 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: 03/10/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic