MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM; DENTAL IMPLANT

Catalog Number	TSVWB13
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported that packaging was open (loss of sterility).Another sterile implant was placed to complete the procedure.No patient impact was reported.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: premarket identification k011028/k013227.
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 received one (1) tsvwb13, (impl tapered scr-v sbm 4.7mm 4.5mm 13mm) for evaluation.Visual evaluation of the as returned devices identified the implant and bundled mount were outside their original packaging, which was not returned for evaluation.The implant had signs of being handle/manipulated by the customer, and there were minor markings on the bundled mount and screw.Measurements match drawing.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 1290542.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 1290542 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿damaged or un-sealed sterile barrier¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation is mishandling of device/packaging outside of zimvie control.Therefore, based on the available information, a packaging malfunction could not be verified.The reported event/coob was non-verifiable since the condition of the product/packaging received by the customer was unknown/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: IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 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: 24647067
• Report Number: 0001038806-2026-01483
• Device Sequence Number: 9918558
• Product Code: DZE
• UDI-Device Identifier: 00889024020061
• UDI-Public: (01)00889024020061(17)291027(10)1290542
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: TSVWB13
• Device Lot Number: 1290542
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/02/2026
• 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: 03/20/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic