BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATTA PELVIC SYSTEM

    MDR report key: 17532983 · Received August 12, 2023

    Report

    Report Number
    MW5139889
    Event Type
    Death
    Date Received
    August 12, 2023
    Report Date
    April 9, 2015
    Manufacturer
    STRYKER
    Product Code
    HRS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, ARORA, R., ET AL. (2007) "MINIMALLY INVASIVE TRANSILIAC PLATE OSTEOSYNTHESIS FOR TYPE C INJURIES OF THE PELVIC RING: A CLINICAL AND RADIOLOGICAL FOLLOW-UP." JOURNAL OF ORTHOPAEDIC TRAUMA (21 : 9: 595-602). THE PATIENTS IN THE STUDY WERE TREATED WITH EITHER AN AO (THE ASSOCIATION FOR THE STUDY OF INTERNAL FIXATION) PELVIC RE-CONSTRUCTION PLATE OR A SMPHYSIS PUBIS PLATE (MATTA PELVIC SYSTEM, STRYKER INC., MI). THERE WERE PATIENT COMPLICATIONS REPORTED WITHIN THE ARTICLE BUT IT IS UNCLEAR WHICH MANUFACTURER'S DEVICE LED TO COMPLICATIONS. THERE WERE TWO REPORTED PLATE BREAKAGES AND ONE BROKEN SCREW WHICH DID NOT REQUIRE ADDITIONAL INTERVENTION. THERE WAS ONE REPORTED DEATH FROM MULTIORGAN FAILURE IN THE EARLY POSTO-PERATIVE PHASE. N/A. 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
    1085787 MATTA PELVIC SYSTEM PLATE, FIXATION, BONE HRS STRYKER

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN SCREW, FIXATION, BONE