MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM; DENTAL IMPLANT

Catalog Number	TSV6B13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: additional pma/510(k) number, k011028|k013227.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.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
It was reported that the cover screw came off the implant at tooth site #5.X-ray imaging confirmed loss of integration, implant mobility and an active infection.Symptoms as a result of the event: abscess and pain.An additional appointment was required to replace and alternate the implant.
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: 10, 4109, 3331 and 4111.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 was performed, slight wear however no damage to the implant was identified that would cause or contribute to the event.Markings due to the removal process.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.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 material selection.Therefore, based on the available information, a device malfunction did not occur.Sight wear however no damage to the implant was identified that would cause or contribute to the event.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.Similar complaints for implant infection have been previously investigated.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.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM
• 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: 23881476
• Report Number: 0001038806-2025-04102
• Device Sequence Number: 9650858
• Product Code: DZE
• UDI-Device Identifier: 00889024019393
• UDI-Public: (01)00889024019393(17)280823(10)1270935
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: TSV6B13
• Device Lot Number: 1270935
• 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: 12/23/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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