MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM; DENTAL IMPLANT

Catalog Number	TSVWB11
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H11: additional narrative.Zimvie received one (1) tsvwb11, (impl tapered scr-v sbm 4.7mm 4.5mm 11.5mm) for evaluation.Visual evaluation was performed, the implant has signs of use with debris on its external threads.The implant was damaged during removal.The implant¿s drive feature was damaged.There was a fractured mount hex stuck inside the implant.The mount was not returned.The customer confirmed that the mount fractured occurred during removal.Dhr review was completed for the subject lot number 1288515.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 1288515 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : damaged drive feature¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was applying too much torque/speed during seating.Therefore, based on the available information, a device malfunction did occur.The implants drive feature was damaged.The reported event was confirmed.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
It was reported that the hex of the implant is damaged and it did not allow the removal of the mount during implant placement.Another implant was placed.Inflammation reported as a result of the event.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: premarket identification pma/510(k) #: k013227.

• Brand Name: IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM
• 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: 24018790
• Report Number: 0001038806-2026-00156
• Device Sequence Number: 10590914
• Product Code: DZE
• UDI-Device Identifier: 00889024020054
• UDI-Public: (01)00889024020054(17)290926(10)1288515
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K061410
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: TSVWB11
• Device Lot Number: 1288515
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/18/2025
• 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: 01/09/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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
• Patient Age: 48 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic