MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 3.7, 10,MTX,MC,MG,HA; DENTAL IMPLANT

Catalog Number	TSVMH10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).A4: patient weight is not provided / unknown.E1: initial reporter¿s title is not provided / unknown.
Event or Problem Description
Implant placement at tooth site #28, surgeon attempts to remove the mount once the implant is inside the pt's mouth, but it would not disengage, implant is then removed and another implant is then placed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b3.Date of event.B4: date of this report.B5: describe event or problem.D4: additional device information.D9: device availability.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.Zimvie received one (1) tsvmh10, (imp, tsv, 3.7, 10, mtx, mc, mg, ha) for evaluation.Visual evaluation was performed, the implants mount wasn¿t returned with the implant.A mount wasn¿t stuck to the implant.Dhr review was completed for the subject lot number 1263816.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 1263816 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: functional: does not disengage/release.The customer did submit images for the reported event.The image was of the implant, no mount was attached.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was likely customer error.Therefore, based on the available information, a device malfunction could not be verified.The implants mount wasn¿t returned stuck to the implant.The reported event 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: IMP, TSV, 3.7, 10,MTX,MC,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: 19756324
• Report Number: 0002023141-2024-02406
• Device Sequence Number: 6513623
• Product Code: DZE
• UDI-Device Identifier: 00889024344099
• UDI-Public: (01)00889024344099(17)280424(10)1263816
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133339
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2024

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: TSVMH10
• Device Lot Number: 1263816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/16/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic