MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM; DENTAL IMPLANT

Catalog Number	TSVWH10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was at the 4 months status post implant placement at tooth site #3 with an internal sinus lift.The patient presented for a torque test with no complaints.The doctor removed the healing abutment from the implant #3.When an attempt was made to reverse torque test the implant, the patient had pain.The implant was dull to percussion and nonmobile.The rfa showed an i-s q of 59.The doctor administered 1 cartridge of 4# septocaine with 1 100,000 epinephrine.The implant failed torque test.The implant was removed in its entirety.There was mucosa associated with the entirety of the implant prep site.This was removed with a curette.The site was copiously irrigated with chlorhexidine followed by normal saline.The initial implant was replaced with another implant.This implant showed excellent initial stability.13mm encode healing abutment's placed on the implant.Seating was confirmed with a radiograph.The patient was given prescriptions for hydrocodone, ibuprofen, chlorhexidine and penicillin.Symptoms as a result of the event: pain.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).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
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: 4109, 4111 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 67 and 4315.H10: narrative/data was updated.Zimvie received the reported implant for evaluation.Visual evaluation was performed, implant had 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 lot number for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was patient factors.Therefore, based on the available information, device malfunction did not occur.No damage to the implant was identified.The reported event was 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: IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 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: 23959912
• Report Number: 0001038806-2026-00027
• Device Sequence Number: 20268725
• Product Code: DZE
• UDI-Device Identifier: 00889024020092
• UDI-Public: (01)00889024020092(17)280912(10)1272361
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 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): 02/20/2026

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: TSVWH10
• Device Lot Number: 1272361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2025
• 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: 01/05/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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: Unknown
• Patient Ethnicity: Non Hispanic