MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V SBM 6M M 5.7MM 10MM; DENTAL IMPLANT

Catalog Number	TSV6B10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Osteolysis (2377)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided.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.
Event or Problem Description
It was reported that erythema/edema distal to #19 implant exists.Sites have healed but noted bone loss #19d based on new pa radiography.Recommended implant removal and replacement.The implant at tooth site #19 was removed due to allergic reaction and bone loss.Symptoms as a result of the event: edema; inflammation; pain & swelling.
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 corrected data and additional information.Correction: the catalog number was updated from ct3110, lot# 1266912 to tsv6b10, lot# unknown.The following sections are being reported: b4: date of this report was updated.D1: brand name was updated.D4: catalog number was updated.D4: lot number unknown / not provided d9: device availability and return date were updated g3: date received by manufacturer was updated.G4: pma/510(k) number was updated.G4: additional pma/510(k) number ¿ k011028 | k013227 g6: type of report was updated.H2: type of follow up was updated.H6: type of investigation codes were added: 4109 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 67 and 4310.H10: narrative/data was updated.Zimvie received the reported implant for evaluation.Visual evaluation was performed, light 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 and complaint history review by lot number could not be performed, as the lot number associated with the reported product is not available.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the implant dating back to 12 months.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/product holds for the reported product for similar event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was material selection.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-conformances 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.Therefore, based on the available information, device malfunction did not occur.The implant has slight wear however no damage to the implant was identified that would cause or contribute to the event.Markings due to the removal process.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.

• Brand Name: IMPL TAPERED SCR-V SBM 6M M 5.7MM 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 22688303
• Report Number: 0002023141-2025-02131
• Device Sequence Number: 5723691
• Product Code: DZE
• UDI-Device Identifier: 00889024343870
• UDI-Public: (01)00889024343870(17)280606(10)1266912
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: TSV6B10
• Device Lot Number: 1266912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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: 59 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic