MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM; DENTAL IMPLANT

Catalog Number	TSVH10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).A4: weight unknown / not provided.G4: additional pma/510(k) number ¿ k011028|k013227.Product has been received by zimvie and the investigation is in process.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 pain.At three month post-operative the patient complained of pain around the implant.An examination showed no issues and x-ray showed no violation to the nerve.Healed well.On (b)(6) 2025, the patient continues to complain about pain.Appears to be nerve pain.Rx given for medrol dose pack for one week and gabapentin 100mg x90 for three times a day.On (b)(6) 2025, the patient continued to have pain.The patient explained that she was having nerve pain even though implant is not on the nerve.Patient was given three options, which was more time to heal, seeing a neurologists, or to remove the implant.On (b)(6) 2025, the patient did see a neurologist.She was prescribed gabapentin but patient was not able to tolerate due to side effects.Due to the unexplained ongoing and persistent symptoms, the next option is to remove implant.Patient desired removal.The implant was removed on (b)(6) 2025.Symptoms as a result of the event: pain.
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 code was added: 10, 4109, 3331 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4315.H10: narrative/data was updated.Zimvie received the complaint device for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent bone / tissue attached to external threads.The implant was identified as reported however, no apparent malfunction was identified with the implant that would contribute to the reported event.Implant matched prints where measured.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.This complaint refers to the specific device being investigated for this complaint record.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 submit one x-ray image for the reported event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation is inadequate treatment planning.Therefore, based on the available information, a device malfunction did not occur.The reported event was non-verifiable with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM
• 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: 23565698
• Report Number: 0001038806-2025-03182
• Device Sequence Number: 10155359
• Product Code: DZE
• UDI-Device Identifier: 00889024019560
• UDI-Public: (01)00889024019560(17)280518(10)1267322
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2023
• 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): 01/12/2026

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: TSVH10
• Device Lot Number: 1267322
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2025
• 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: 11/16/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2023
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic