MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V SBM 6M M 5.7MM 8MM; DENTAL IMPLANT

Catalog Number	TSV6B8
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).Zimvie received one (1) tsv6b8, (impl tapered scr-v sbm 6m m 5.7mm 8mm) for evaluation.Visual evaluation was performed, the implant had signs of use/wear with bone debris on the external threads.No damage identified or signs of malfunction that would have contributed to the event.Measurements match.Device history record (dhr) review was completed for the subject lot number 1250614.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 1250614 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: medical: allergic reaction.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error or patient factors.Therefore, based on the available information, a 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.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.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.G4: premarket identification: k011028|k013227.
Event or Problem Description
It was reported that the implant on tooth location 27 was removed due to allergic reaction.Pain reported as a consequence of the event.Patient will return to complete the procedure.Bone type iii.

• Brand Name: IMPL TAPERED SCR-V SBM 6M M 5.7MM 8MM
• 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: 21504854
• Report Number: 0002023141-2025-00528
• Device Sequence Number: 19945565
• Product Code: DZE
• UDI-Device Identifier: 00889024019416
• UDI-Public: (01)00889024019416(17)261214(10)1250614
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 05/31/2025

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: Lay User/Patient
• Device Catalogue Number: TSV6B8
• Device Lot Number: 1250614
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/07/2025
• 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: 03/03/2025
• Supplement Report FDA Received Date: 06/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• 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: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic