BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 2061743 · Received April 18, 2011

    Report

    Report Number
    2953769-2011-00050
    Event Type
    Injury
    Date Received
    April 18, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: FOLLOW-UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE AT LEVEL T12 ON (B)(6) 2008 AT (B)(6) MEDICAL CENTER; DISCHARGED ON (B)(6) 2008. PATIENT'S FIRST POSTOPERATIVE VISIT WAS ON (B)(6) 2008. BETWEEN (B)(6) 2008 AND (B)(6)2008, PATIENT EXPERIENCED LOW BACK PAIN AND A SENSATION OF PARALYSIS. ON (B)(6) 2008, PATIENT PRESENTED HIMSELF TO THE EMERGENCY DEPARTMENT FOR SEVERE LOW BACK PAIN, DIFFICULTY WALKING AND FEVER. PATIENT UNDERWENT DIAGNOSTIC TESTING, BLOOD TESTING, AND WAS GIVEN PAIN MEDICATION. PATIENT'S BLOOD TESTING REVEALED A SYSTEMIC INFECTION, AND HIS SPINE WAS FOUND TO BE UNSTABLE WITH A MARKED KYPHOSIS. ON (B)(6) 2008, PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL, DUE TO PATIENT'S UNS TABLE THORACIC SPINE INJURY WITH OSTEOMYELITIS. ON (B)(6) 2008, PATIENT WAS REQUIRED TO UNDERGO CORRECTIVE REMOVAL OF KYPHOPLASTY CEMENT FROM EPIDURAL SPACE; DISCECTOMIES AT MULTIPLE LEVELS OF THORACIC AND LUMBAR SPINE SURGERY, INCLUDING INSTRUMENTED FUSIONS AT MULTIPLE THORACIC AND LUMBAR SPINE LEVELS; PLACEMENT OF EXPANDABLE STRYKER CAGE. AFTER THE (B)(6) 2008 SURGERY, PATIENT WAS CONTINUED ON IV ANTIBIOTICS FOR NINE DAYS. ON (B)(6) 2008, PATIENT WAS TRANSFERRED TO REHABILITATION. PATIENT WAS RELEASED TO GO HOME ON (B)(6) 2008. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SPINE LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Other| R