MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,MCOL MG,3.7MM,8MM; DENTAL IMPLANT

Catalog Number	TSVMB8
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age at time of the event unknown / not provided.A4: patient weight unknown / not provided.
Event or Problem Description
Follow up was done with clinician on (b)(6) 2025 and was advised that the patient was referred to the office with a fractured implant collar.Patient arrived with a loose crown and when primary dentist assessed site, found fractured collar.General dentist removed abutment and placed a healing collar until removal.Patient scheduled removal after she got back form going out of country.Identified abutment loose was a fractured collar on (b)(6) 2025.Delayed removal (b)(6) 2025.Surgical/medical intervention required for permanent damage: implant removed.Additional appointment required: yes.Symptoms as a result of the event: inflammation.Grafted: grafted at removal.Bone type: unknown.Tooth site: 30.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: this report is being submitted to retract the initial report, mfr report number 0002023141-2025-02456 that was submitted on september 8, 2025 as this event had already been submitted and is a duplicate of mfr report number 0002023141-2025-02390 that was submitted on august 29, 2025.Therefore, no additional reports will be submitted under mfr report number 0002023141-2025-02456.This complaint will be closed as a duplicate and the investigation results will be documented and processed under manufacturer report #0002023141-2025-02390.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H10: narrative/data was updated.
Event or Problem Description
This report is being submitted to retract the initial report, mfr report number 0002023141-2025-02456 that was submitted on september 8, 2025 as this event had already been submitted and is a duplicate of mfr report number 0002023141-2025-02390 that was submitted on august 29, 2025.Therefore, no additional reports will be submitted under mfr report number 0002023141-2025-02456.

• Brand Name: IMP,TSV,MCOL MG,3.7MM,8MM
• 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: 23001279
• Report Number: 0002023141-2025-02456
• Device Sequence Number: 8997385
• Product Code: DZE
• UDI-Device Identifier: 00889024019768
• UDI-Public: (01)00889024019768(17)230430(10)64029656
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: 2018
• Device Explanted Year: 2025
• 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): 10/07/2025

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: TSVMB8
• Device Lot Number: 64029656
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2025
• 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: 09/09/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic