MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.7,13,MTX,MG; DENTAL IMPLANT

Catalog Number	TSVTWB13
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.G4: additional pma/510(k) number k101880.
Event or Problem Description
It was reported that the implant at tooth site #19 was missing the center screw.No center screw in packed implant, so implant fell out when dr placed carrier.Procedure was completed using another implant.There was a delay during the procedure, had to get additional rda to open cabinet to retrieve another and open.
Additional Manufacturer Narrative
Zimvie received one (1) tsvtwb13, (imp,tsv,4.7,13,mtx,mg) for evaluation.Visual evaluation was performed.The returned implant / packaging matched the reported implant.The tamper seal / ring was broken.No damage and slight markings on implant due to usage.Mount screw is present and threads into implant as intended.Cal4063 due 30 may 2025.The coob is non-verifiable as the condition of the implant / packaging when received by the customer is unknown / non-verifiable.Dhr review was completed for the subject lot number 1288595.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 1288595 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 matched the reported implant.The tamper seal / ring was broken.Mount screw is present and threads into implant as intended, however, we cannot confirm that this is the original reported screw.The coob is non-verifiable as the condition of the implant / packaging when received by the customer is 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.The following sections have been updated: b4: date of this report.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.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 available at the time of this report.

• Brand Name: IMP,TSV,4.7,13,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: 21829801
• Report Number: 0002023141-2025-00941
• Device Sequence Number: 21207363
• Product Code: DZE
• UDI-Device Identifier: 00889024020016
• UDI-Public: (01)00889024020016(17)291003(10)1288595
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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 Catalogue Number: TSVTWB13
• Device Lot Number: 1288595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• 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: 04/11/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic