BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATOS

    MDR report key: 4193541 · Received September 11, 2014

    Report

    Report Number
    3006801247-2014-00004
    Event Type
    Injury
    Date Received
    September 11, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDXPERT GMBH
    Product Code
    HRS
    PMA / PMN Number
    K073556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PECTUS EXCAVATUM (PE) TREATMENT WAS PERFORMED WITH ONE BRIDGE, CONSISTING OF ONE BAR AND TWO CLIPS. THE RECOMMENDATION FOR PE IS THE USE OF 3 BRIDGES. THE REOPERATION (EXPLANTATION) WAS PERFORMED 19 MONTHS AFTER IMPLANTATION. THE DECISION IF OR WHEN TO REMOVE IMPLANTS RESTS WITH THE SURGEON. IN ANY EVENT, POSTOPERATIVE EVALUATION OF THE PT IS MANDATORY. IT IS RECOMMENDED TO SEE EACH PT IN REASONABLE INTERVALS (EVERY 4-6 MONTHS). MATERIAL WAS NOT AVAILABLE DURING THIS REPORT FOR AN INSPECTION. LOT NUMBERS ARE NOT AVAILABLE FOR REPORTING ABOUT PRODUCTION AND MATERIAL DETAILS.

    Description of Event or Problem · 1

    DEFORMITY TREATMENT PECTUS EXCAVATUM, DETAILS (HALLER INDEX, SYMMETRIC/ASYMMETRIC) ARE NOT AVAILABLE. PT = FEMALE, BORN (B)(6) 1991. OPERATION DATE: (B)(6) 2012. THE 2 STRATOS CLIPS REF 012-02450, BOTH BROKEN IN THE ANGLE DATE OF BREAKAGE NOT DETECTABLE, POST-OPERATIVE PROBLEMS/OBSERVATIONS: WOUND PAIN. EXPLANTATION (B)(6) 2014. PRODUCTS AVAILABLE FOR INSPECTION: NO INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563323 STRATOS TITANIUM RIB CLIPS HRS MEDXPERT GMBH 012-02450 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1