MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,MCOL MG,3.7MM,13M; DENTAL IMPLANT

Catalog Number	TSVMB13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.A2: age at time of the event: unknown / not provided.A3: gender: unknown / not provided.A4: patient weight: unknown / not provided.D6: d6a.If implanted, give date: unknown.D10: concomitant medical product: tsvmb11, imp,tsv,mcol mg,3.7mm,11.5mml, lot: 1294518 tsv4b10, imp,tsv,4.1mm,sbm,10, lot: 1282441.E1: reporter name: unknown / not provided.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
The doctor reports that the dental implants failed due to infection and were removed.Pain was reported as a result of the event.The procedure was concluded by placing another implants.

• Brand Name: IMP,TSV,MCOL MG,3.7MM,13M
• 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: 22024447
• Report Number: 0002023141-2025-01279
• Device Sequence Number: 15263469
• Product Code: DZE
• UDI-Device Identifier: 00889024019744
• UDI-Public: (01)00889024019744(17)290303(10)1278111
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111889
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

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: TSVMB13
• Device Lot Number: 1278111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANTS SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic