MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,6.0,8,MTX,MG; DENTAL IMPLANT

Catalog Number	TSVT6B8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sinus Perforation (2277)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: additional pma/510(k) number ¿ k101880.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant at tooth site #19 was removed due to sinus perforation.It was reported that the implant had failed due to sinus communication.A sinus elevation procedure was conducted to promote patient healing.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4114, 4111 and 3331.H6: investigation findings code was added: 213 h6: investigation conclusions code was added: 4315 and 67.H10: narrative/data was updated.Zimvie received the reported device for evaluation.Visual evaluation / functional test was performed, no damage identified or signs of malfunction that would contribute to the event.Dhr review was completed for the subject lot number.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 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: medical: perforated sinus.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 from the investigation was clinician inadvertently selects an length of implant that is too long for the depth of osteotomy prepared.Therefore, based on the available information, a device malfunction did not occur.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 products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: IMP,TSV,6.0,8,MTX,MG
• 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: 22688624
• Report Number: 0002023141-2025-02133
• Device Sequence Number: 5996759
• Product Code: DZE
• UDI-Device Identifier: 00889024019911
• UDI-Public: (01)00889024019911(17)291010(10)1288821
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/26/2025

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: Other
• Device Catalogue Number: TSVT6B8
• Device Lot Number: 1288821
• Was Device Available for Evaluation?: No
• 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: 08/01/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic