MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 6.0, 13, MTXF, MG,HA; DENTAL IMPLANT

Catalog Number	TSVT6H13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported screw from fmt5 was not secure when removing from package.Caused implant to drop on ground and no be useable.No symptoms as a result of the event.Doctor indicated no impact to the patient.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age at time of the event unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.G4: premarket identification k133339.
Additional Manufacturer Narrative
Zimvie received one (1) tsvt6h13, (imp, tsv, 6.0, 13, mtxf, mg, ha) for evaluation.Visual evaluation and a functional test was performed; the implant was not returned in the original packaging.The implant shows no signs of wear/use.Functionally tested with returned mount and screw and it engages and disengages as indented.No malfunction identified.Dhr review was completed for the subject lot number 1260389.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 1260389 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: functional: disengaged¿.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 was likely improper handling of product outside of zimvie controls.Therefore, based on the available information, a packaging malfunction could not be verified.The implant was not returned in its original packaging.However, the implant performed as intended during a functional test.The reported event was 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.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP, TSV, 6.0, 13, MTXF, MG,HA
• 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: 21418655
• Report Number: 0002023141-2025-00451
• Device Sequence Number: 13093208
• Product Code: DZE
• UDI-Device Identifier: 00889024344266
• UDI-Public: (01)00889024344266(17)280202(10)1260389
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101880
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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: Health Professional
• Device Catalogue Number: TSVT6H13
• Device Lot Number: 1260389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• 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: 02/20/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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