BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATOS

    MDR report key: 4193549 · Received September 11, 2014

    Report

    Report Number
    3006801247-2014-00007
    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 CARINATUM (PC) TREATMENT WAS PERFORMED WITH TWO BRIDGES, CONSISTING OF ONE BAR AND TWO CLIPS. THE RECOMMENDATION FOR PC IS THE USE OF 3 BRIDGES. THE REOPERATION (EXPLANTATION) WAS PERFORMED 28 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 PRODUCT AND MATERIAL DETAILS. FROM THE QUANTITIES AND PRODUCT CODES ON THE DISTRIMED REGISTRATIEFORMULIER, THE REF INDICATED IN THE QUALITY SYSTEM REPORT FORM AND THE PRODUCTS SHOWN ON THE XRAY IT IS NOT CLEAR WHICH PRODUCTS WERE USED.

    Description of Event or Problem · 1

    DEFORMITY TREATMENT PECTUS CARINATUM, MORE DETAILS (SYMMETRIC/ASYMMETRIC) ARE NOT AVAILABLE. PT = FEMALE, BORN (B)(6) 1986. OPERATION DATE: (B)(6) 2012. STRATOS CLIPS REF UNK, STRATOS BAR: 014-10190. THE CLIP BROKE IN THE ANGLE OF THE CLIP DATE OF INCIDENT NOT DETECTABLE. EXPLANTATION (B)(6) 2014. PRODUCTS AVAILABLE FOR INSPECTION: NO INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563240 STRATOS TITANIUM RIB CLIPS HRS MEDXPERT GMBH UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1