BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    MDR report key: 7996653 · Received October 23, 2018

    Report

    Report Number
    0002023141-2018-00856
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    December 18, 2017
    Report Date
    February 26, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    A SINGLE TSV IMPLANT (TSVB13) WAS RETURNED FOR INVESTIGATION. THE IMPLANT WAS VISUALLY INSPECTED UNDER MAGNIFICATION AND PHOTOGRAPHED. THE IMPLANT WAS CAKED IN ORGANIC MATERIAL, PREVENTING RELIABLE MEASUREMENTS, BUT OTHERWISE SHOWED NO SIGNS OF SIGNIFICANT DAMAGE OR DEFORMATION. REVIEW OF PATIENT INFORMATION SHOWS A NUMBER OF PATIENT FACTORS THAT LIKELY AFFECTED THE REPORTED EVENT, INCLUDING A HISTORY OF CANCER, INFECTION, AND OSTEOPOROSIS. DHR REVIEW REVEALED NO EVIDENCE OF A MANUFACTURING OR STERILIZATION NONCONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE PRODUCT LEFT ZIMMER BIOMET CONTROL IN CONFORMANCE WITH ALL APPLICABLE STANDARDS. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. ALSO A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. BASED ON THE INVESTIGATION OF THE AVAILABLE INFORMATION AND RETURNED DEVICE, PRODUCT MALFUNCTION COULD NOT BE CONFIRMED. A SINGULAR ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    REPORTER'S LAST NAME AND EMAIL ADDRESS NOT PROVIDED. ADDITIONAL 510(K) NUMBERS: K011028 AND K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (TSVB13) WAS REMOVED DUE TO OSTEONECROSIS OF THE UPPER MAXILLA. PATIENT UNDERWENT THROUGH BREAST CANCER SURGERY. PATIENT TAKING RALOXIFENE DUE TO CANCER, ALENDRONATE AND DUE TO OSTEOPOROSIS AND CORTICOSTEROID DUE TO EPOC. DOCTOR ALSO INDICATED THAT THE PATIENT HAS BEEN TAKING ALENDRONATE FOR MORE THAN 3 YEARS (DID NOT KNOW THE EXACT PERIOD OF TIME) PATIENT HAD BREAST CANCER 5 YEARS AGO AND CORTICOSTEROID DUE TO EPOC PATIENT HAD BEEN TAKING FOR THE LAST 2 OR MORE YEARS. NOW PATIENT IS IN HEALING PROCESS TAKING ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838262 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM IMPLANT DZE ZIMMER DENTAL 0510829

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention