BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RECON PLATE

    MDR report key: 12916653 · Received December 2, 2021

    Report

    Report Number
    0008031020-2021-00481
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    January 1, 2017
    Report Date
    December 2, 2021
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    LINKED TO (B)(4): IN (B)(6) 2017, A FISTULA APPEARED ON THE SCAR JUSTIFYING A BACTERIOLOGICAL SAMPLE WHICH CONFIRMED THE PRESENCE OF STAPHYLOCOCCUS COLONIES JUSTIFYING HIS HOSPITALIZATION IN THE INFECTIOUS DISEASE DEPARTMENT OF THE TIMONE IN MARSEILLE WHERE SHE BENEFITED FROM A CLEANING AND THEN ANTIBIOTIC INFUSIONS. THE TREATMENT BEING POORLY TOLERATED, SHE WAS THE SUBJECT OF A NEW HOSPITALIZATION IN (B)(6) 2017 WHERE PATIENT WAS OFFERED A NEW ORAL TREATMENT. ON THIS OCCASION, IT APPEARED FROM THE IMAGERY THAT THE MATERIAL HAD BROKEN AGAIN. THIS INTERVENTION WAS FOLLOWED BY AN EARLY BANKRUPTCY OF THE MECHANICAL ASSEMBLY, NOTED TWO AND A HALF MONTHS LATER, ON (B)(6) 2017, WITH DISMANTLING OF THE EQUIPMENT. FROM THE BEGINNING OF (B)(6) 2017, SKIN FISTULIZATION OCCURRED. SUPERFICIAL SWABS TAKEN ON (B)(6) 2017, ISOLATED RARE COLONIES OF STAPHYLOCOCCUS AUREUS. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2017 AT THE PRIVATE HOSPITAL RESIDENCE OF THE PARK BY DR. B. FOR WASHING AND DEEP SAMPLES, WHICH FOUND PROPIONIBACTERIUM ACNES. ANTIBIOTIC THERAPY WITH VANCOMYCIN, FOLLOWED BY TARGOCID AND DALACINE IN VIEW OF THE ANTIBIOGRAM, WAS INITIATED. PATIENT WAS THEN HOSPITALIZED AT THE AP-HM FROM (B)(6) 2017 FOR ADAPTATION OF THE ANTIBIOTIC THERAPY. SHE RETURNED HOME ON (B)(6) 2017 UNDER COVER OF AN UPPER LIMB ORTHOSIS. SHE WAS HOSPITALIZED AGAIN, DUE TO DRUG REACTIONS TO ANTIBIOTICS, FOR FOLLOW-UP AND ADAPTATION OF ANTIBIOTIC THERAPY, FROM (B)(6) 2017, FROM (B)(6) 2017. THIS IS 3 OUT OF 4 EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818039 UNKNOWN RECON PLATE IMPLANT HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H