MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1,13,MTX,MG; DENTAL IMPLANT

Catalog Number	TSVT4B13
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported implant was received, however when customer opened plastic container there was no implant inside.Event happened during a procedure but no impact to the patient.Used new implant.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) tsvt4b13, (imp,tsv,4.1,13,mtx,mg) for evaluation.Visual evaluation was performed.The returned implant packaging was identified as reported.The outer vial's tamper seal / ring was in unsealed condition.Inner vial was empty and implant and mount were missing.The coob is non-verifiable as the condition of the product when received by the customer is unknown / non-verifiable.Dhr review was completed for the subject lot number 1245372.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 1245372 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : packaging : incorrect component quantity.¿ the customer did not submit images for the reported event.Based on the investigation, the most likely root cause determined was improper handling of devices/packaging outside of zimvie controls.Therefore, based on the available information, a device malfunction could not be verified.The returned implant packaging was identified as reported.The outer vial's tamper seal / ring was in unsealed condition.Inner vial was empty and implant and mount were missing.The coob is non-verifiable as the condition of the product when received by the customer is unknown / non-verifiable.The reported event/coob could not be verified since the condition of the product/packaging when 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.The following sections have been updated: b4: date of this report d9: device availability g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.

• Brand Name: IMP,TSV,4.1,13,MTX,MG
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 21676206
• Report Number: 0002023141-2025-00762
• Device Sequence Number: 20910614
• Product Code: DZE
• UDI-Device Identifier: 00889024019843
• UDI-Public: (01)00889024019843(17)260616(10)1245372
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: Lay User/Patient
• Device Expiration Date: 06/16/2026
• Device Catalogue Number: TSVT4B13
• Device Lot Number: 1245372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/24/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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