MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,MCOL MG,6.0MM,10MM,MTX; DENTAL IMPLANT

Catalog Number	TSVM6B10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient had implant placed (b)(6) 2024.Came in 10/28/ for regular follow up.Patient experienced sensitivity.Let heal until (b)(6).Still sensitive.Prescribed levaquin 500 for 7 days.Tooth site: 19.
Additional Manufacturer Narrative
Zimvie did not receive one (1) tsvm6b10, (imp,tsv,mcol mg,6.0mm,10mm,mtx) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).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 1266243r.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 1266243r for similar events and one (1) other complaint was identified ((b)(4)).Review completed utilizing keywords: ¿medical other¿.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rmf rm-00541-haz rev.4, the most likely root cause determined from the investigation is inadequate treatment planning.Therefore, based on the available information, a device malfunction could not be verified.Without device receipt, the reported event is non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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 available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: additional pma/510(k) number k101880.

• Brand Name: IMP,TSV,MCOL MG,6.0MM,10MM,MTX
• 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: 21894382
• Report Number: 0002023141-2025-01060
• Device Sequence Number: 8082614
• Product Code: DZE
• UDI-Device Identifier: 00889024019676
• UDI-Public: (01)00889024019676(17)290101(10)1266243R
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111889
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: TSVM6B10
• Device Lot Number: 1266243R
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/24/2025
• 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: 04/23/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic