MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP,TSV,MCOL MG,4.7MM,10M; DENTAL IMPLANT

Catalog Number	TSVMWB10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth site #31 was removed due to bone loss and pain.The tooth was extracted with bone grafting on (b)(6) 2022.The implant was placed, fully guided, on (b)(6) 2025 uneventfully.The patient was sent for follow-up on (b)(6) 2025 and there was no issue detected with healing, but the patient had discomfort.She mostly pointed extra orally toward the temporomandibular joint and thought that it might be related to opening during surgery and decided to follow up in three weeks.The patient was seen on (b)(6) 2025 and she felt better but i noted suppuration on the buccal of the implant with mild inflammation.It was thought that it might be the encode impinging on the soft tissue.The patient was anesthetized and the encode was removed.Bone loss was noted between the implant and the buccal bone wall.The patient had pain when touching the implant.It was decided to remove the implant and graft the tooth site.An additional appointment was anticipated after the site was healed to replace the implant.Symptoms as a result of the event: abscess, pain and inflammation.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).G4: additional pma/510(k) number ¿ k101880.A summary investigation has been completed for bone loss events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for bone loss have not identified any signals indicating potential non-conformance's affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
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.D9: device availability and return date were 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 code was added: 3331 and 4110.H10: narrative/data was updated.Zimvie received the reported device for evaluation.Visual evaluation was performed.The implant has signs of use.The implant has markings from removal.There was no damage identified or signs of malfunction that would have contributed to the event.Measurements match drawing.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 lot number for similar events and no other complaint was identified.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 possibly user caused.Therefore, based on the available information, a device malfunction did not occur.The returned implant shows signs of wear/use, however, no damage that would cause or contribute to the event was identified.The reported event was non-verifiable.Bone loss is a non-verifiable event as well.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.Similar complaints for bone loss related problems have been previously investigated.Refer to attached summary investigation.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.

• Brand Name: IMP,TSV,MCOL MG,4.7MM,10M
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23726640
• Report Number: 0001038806-2025-03609
• Device Sequence Number: 13441849
• Product Code: DZE
• UDI-Device Identifier: 00889024019775
• UDI-Public: (01)00889024019775(17)300324(10)1297163
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K111889|K101
• 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): 02/02/2026

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: TSVMWB10
• Device Lot Number: 1297163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/05/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic