BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTUS CANNULATED COMPRESSION SCREWS

    MDR report key: 20480795 · Received October 18, 2024

    Report

    Report Number
    3003236702-2024-00001
    Event Type
    Injury
    Date Received
    October 18, 2024
    Date of Event
    October 5, 2022
    Report Date
    October 17, 2024
    Manufacturer
    MEDARTIS AG
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDARTIS AG HAS ALREADY ASSESSED THE REPORTED ISSUE WITH THE FOLLOWING CONCLUSION: MEDARTIS APTUS CCS ARE MANUFACTURED FROM TI6AL4V ALLOY ACC. TO ASTM F136 WITH THE FOLLOWING COMPOSITION. ALUMINUM 3.5% - 4.5%, VANADIUM 5.5% - 6.75%, NITROGEN <0.05%, CARBON <0.08%, HYDROGEN <0.015%, IRON <0.3%, OXYGEN <0.2%, TITANIUM REST. NI-CONTENT IS BELOW 0.1% AND APTUS CCS ARE TYPICALLY CONSIDERED NI-FREE. AT THE TIME ASSESSING THE COMPLAINT, MEDARTIS AG CONSIDERED THIS COMPLAINT AS NOT REPORTABLE. HOWEVER, AFTER OUR LAST FDA AUDIT, WE RECEIVED THE INFORMATION, THAT THIS WAS NOT TRUE. THEREFORE THE CAPA DEV1457 WAS CREATED TO ADDRESS THE ISSUE. ONE PART OF IT IS TO REPORT THIS ISSUE TO THE FDA, WHAT IS THE REASON FOR THIS REPORT.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: ON (B)(6) 2022, PATIENT WAS TREATED FOR FRACTURES IN TWO ELBOWS BY INSERTING SCREWS AND A METAL PLATE. PATIENT NOW HAS SUSPICION OF A NICKEL ALLERGY AND THE REGIONS AROUND THE SURGICAL SCARS REGULARLY SHOW ITCHY REDNESS. PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE. PATIENT HAS INQUIRED TO FIND OUT WHICH MATERIAL THE METAL PARTS USED AT THAT TIME ARE MADE OF AND WHETHER THEY CONTAIN NICKEL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848245 APTUS CANNULATED COMPRESSION SCREWS SCREW, FIXATION, BONE HWC MEDARTIS AG A-578X.XX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other