BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX 11 GAUGE BONE ACCESS NEEDLE

    MDR report key: 1344668 · Received March 11, 2009

    Report

    Report Number
    2953769-2009-00023
    Event Type
    Injury
    Date Received
    March 11, 2009
    Report Date
    February 12, 2009
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    HRX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: "1150 KYPHOPLASTIES OVER 7 YEARS: INDICATIONS, TECHNIQUES, AND INTRAOPERATIVE COMPLICATIONS" BY NICHOLAS MCARTHUR, MD CHRISTIAN KASPERK, MD; MARTIN BAIER, MD; MICHAEL TANNER, MD; BERND GRITZBACH, MD; OLIVER SCHOIERER, MD; WOLFRAM ROTHFISCHER, MD; GERHARD KROHMER, MD; JOCHEN HILMEIER, MD; HANS-JURGEN KOCK, MD; PETER JURGEN MEEDER, MD; FRANZ-XAVER HUBER, MD TAKEN FROM ORTHO SUPERSITE, ORTHOPEDICS 2009;32:90. - OTHER, DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE.

    Description of Event or Problem · 1

    IN A LITERATURE REVIEW, IT WAS REPORTED THAT FOLLOWING A KYPHOPLASTY PROCEDURE, A PATIENT COMPLAINED OF SEVERE POSTOPERATIVE PAIN TOGETHER WITH SEVERE SWELLING DUE TO A SUBCUTANEOUS HEMATOMA IN THE AREA OF THE SURGICAL INCISION. FOLLOWING SURGICAL EVACUATION OF THE HEMATOMA THE PATIENT REPORTED NO FURTHER COMPLICATIONS. IT WAS REPORTED PER THE AUTHOR THAT THE POSTOPERATIVE HEMORRHAGE RESULTED FROM AN UNKNOWN REGULAR INTAKE OF ASPIRIN. IT IS NOT CERTAIN WHETHER A SCALPEL OR KYPHOPLASTY DEVICE CAUSED A HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX 11 GAUGE BONE ACCESS NEEDLE ACCESS NEEDLE HRX MEDTRONIC SPINE LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R