BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE ANCHORAGE MTP / CROSS PLATE - RIGHT

    MDR report key: 3013713 · Received March 20, 2013

    Report

    Report Number
    0008031020-2013-00063
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    December 1, 2012
    Report Date
    February 21, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K083447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE PLATE BROKE COULD BE CONFIRMED SINCE THE RETURNED DEVICE MATCHES THE REPORTED FAILURE. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. PLEASE NOTE THAT THE OP TECH READS: THE PRODUCT DOES NOT ALLOW THE IMMEDIATE RESUMPTION OF ACTIVITY BY THE PATIENT AND IS NOT DESIGNED TO SUPPORT AN IMMEDIATE LOAD. IMMOBILIZATION IS NECESSARY DURING THE OSTEOSYNTHESIS. THE CLINICAL RESULT DEPENDS ON THE SUITABLE CHOICE OF THE DEVICE FOR THE INDICATION AND ON THE QUALITY OF THE SURGICAL PROCEDURE. IT IS NECESSARY TO INFORM THE PATIENT OF THE PRECAUTIONS TO BE TAKEN TO ENSURE THE SUCCESS OF THE IMPLANTATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A SIMILAR RETURNED DEVICE FROM THE SAME LOT NUMBER WAS SENT TO (B)(4) FOR MICROFRACTOGRAPHIC EXAMINATION. THE RESULTS CAN BE SUMMARIZED IN KEY STATEMENTS AS FOLLOWS: THE FRACTURE SURFACE HAD SUFFERED SEVERE SECONDARY DAMAGE. EVIDENCE OF MICROSCOPIC VIBRATION FRACTURE CHARACTERISTICS WAS FOUND ON THE FRACTURE SURFACE. INTERPRETATION OF THE RESULTS: MICROFRACTOGRAPHIC EXAMINATION SHOWED THAT THE PLATE FAILED DUE TO A VIBRATION FRACTURE (FATIGUE FRACTURE). BECAUSE OF THE SECONDARY DAMAGE, A FRACTURE ORIGINATION POINT COULD NOT BE IDENTIFIED. THE CONCLUSION TO BE DRAWN FROM THE ORIENTATION OF THE STRIATIONS IS THAT THE PLATE WAS SUBJECTED TO ALTERNATING BENDING STRESS. PROVIDED X-RAYS WERE ANALYZED BY CLINICAL EXPERT, THE REPORTED EVENT THAT THE PLATE BROKE COULD BE CONFIRMED SINCE THE RETURNED DEVICE MATCHES THE REPORTED FAILURE . A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; "I HAVE ONE OF YOUR PRODUCTS IN MY FOOT, SURGICALLY IMPLANTED LAST (B)(6), AND THIS THING HAS ALREADY BROKEN IN HALF. I AM SCHEDULED FOR ANOTHER PROCEDURE IN TWO WEEKS, FOR THE PURPOSE OF REMOVING THE FAILED PLATE, AND INSTALLING A NEW ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; "I HAVE ONE OF YOUR PRODUCTS IN MY FOOT, SURGICALLY IMPLANTED LAST DECEMBER, AND THIS THING HAS ALREADY BROKEN IN HALF. I AM SCHEDULED FOR ANOTHER PROCEDURE IN TWO WEEKS, FOR THE PURPOSE OF REMOVING THE FAILED PLATE, AND INSTALLING A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115987 PLATE ANCHORAGE MTP / CROSS PLATE - RIGHT IMPLANT HRS STRYKER OSTEOSYNTHESIS-SELZACH AH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R