BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSS PLATE MTP, RIGHT ANCHORAGE

    MDR report key: 20745897 · Received November 21, 2024

    Report

    Report Number
    0008031020-2024-00628
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    October 23, 2024
    Report Date
    March 3, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    UDI-DI
    07613252473343
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PLEASE REFER TO SECTION H6 (CLINICAL SIGNS CODE). THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. UNDER 510(K)# K083447. THE REPORTED EVENT COULD BE CONFIRMED SINCE THE DEVICE WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE. THE RECEIVED ANCHORAGE PLATE WAS FOUND TO BE BROKEN FROM THE CROSS-PLATE HOLE REGION, TYPICALLY WHERE THE FRACTURE LINE IS. THE NATURE OF BREAKAGE EXHIBITS A TYPICAL FATIGUE FAILURE EVIDENT BY PLASTIC DEFORMATION ALONG THE EDGES AND SOME OF THE BREAKAGE SURFACES, WHICH NORMALLY HAPPENS WHEN ONE SEGMENT SEPARATES GRADUALLY (FATIGUE MANNER) AND RUBS OVER THE OTHER SURFACE. THE FRACTURE APPEARS TO HAVE BEEN CAUSED DUE TO OVERLOADING OVER A LONG PERIOD. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. WITH THE AVAILABLE MEDICAL REPORTS AND X-RAYS, A MEDICAL OPINION WAS SOUGHT FROM OUR HCP WHICH STATED THAT: ¿WITH REGARD TO THE PLATE BREAKAGE. IT MAY BE MULTIFACTORIAL HERE, THE HCP DESCRIBES, METALOSIS, SYNOVITIS AND A FIBROUS UNION. THIS MEANS THERE IS NO BONY UNION, SO IT IS A NON-UNION. A FIBROUS UNION STILL HAS PERSISTENT MOVEMENT IN THE FRACTURE/ ARTHRODESIS AREA, WHICH ULTIMATELY WILL LEAD TO IMPLANT BREAKAGE. THERE IS A LOCAL METALOSIS, WHICH MIGHT HAVE CONTRIBUTED TO A PERSISTENT INFLAMMATORY RESPONSE IN THE AREA OF THE ARTHRODESIS. THIS MIGHT HAVE NEGATIVELY INFLUENCED THE BONE HEALING PROCESS.¿ BASED ON THE ABOVE INVESTIGATION, THE ROOT CAUSE OF THE ISSUE IS MULTIFACTORIAL BUT MOSTLY CAN BE ATTRIBUTED TO USER RELATED FACTORS. THE PLATE APPEARS TO HAVE BROKEN DUE TO FATIGUE UNDER NON-UNION INDUCED OVERLOADING OVER A LONG PERIOD OF TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "1ST MTPJ ANCHORAGE PLATE BROKEN. PATIENT EXPERIENCED PAIN AND SWELLING AT SITE OF SURGERY , X RAYS SHOWED A FRAGMENT OF METAL ABOVE THE PLATE. THE PLATE WAS REMOVED WITH SIGNIFICANT METALLOSIS IN THE SOFT TISSUES PATIENT HAD TO HAVE SECOND SURGERY EPISODE TO REMOVE THE BROKEN PLATE."

    Description of Event or Problem · 0

    AS REPORTED: "1ST MTPJ ANCHORAGE PLATE BROKEN. PATIENT EXPERIENCED PAIN AND SWELLING AT SITE OF SURGERY, X RAYS SHOWED A FRAGMENT OF METAL ABOVE THE PLATE. THE PLATE WAS REMOVED WITH SIGNIFICANT METALLOSIS IN THE SOFT TISSUES. PATIENT HAD TO HAVE SECOND SURGERY EPISODE TO REMOVE THE BROKEN PLATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427424 CROSS PLATE MTP, RIGHT ANCHORAGE PLATE, FIXATION, BONE HRS STRYKER GMBH D52646 07613252473343

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention