BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 12055979 · Received June 24, 2021

    Report

    Report Number
    1030489-2021-00842
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    October 1, 2009
    Report Date
    June 24, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. OTHER: ANOXIA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE CONSUMER VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A L2-L3 LUMBAR KYPHOPLASTY PROCEDURE. IT WAS REPORTED THAT THE BONE CEMENT DEPARTED THE VERTEBRAL BODIES, HARDENING IN THE OUTSIDE SPACES. THE PATIENT HAD LOWER BACK PAIN. THE PATIENT CONTINUED HIS PHYSICAL THERAPY. MRI DONE ON (B)(6) 2016 SHOWED DISC PROTRUSION FROM L1 TO S1. NCV DONE (B)(6) 2020, CONFIRMED LUMBAR RADICULOPATHY. PATIENT MEDICATION: HYDROCODON, TOPOMAX, CBD OIL AND MEDICAL MARIJUANA. PATIENT HISTORY: STATUS POST CRUSH INJURY L2, L3 AND L5 WITH FAILED SURGICAL REPAIR. LUMBAR RADICULOPATHY PROCEDURE DETAILS: PATIENT UNDERWENT KYPHOPLASTY OF THE LUMBAR SPINE AT L2 AND L3. THEN A FURTHER KYPHOPLASTY FOR L5 DURING WHICH L4 WAS MISTAKENLY ADDRESSED. PATIENT OUTCOME: PATIENT ASPIRATED CAUSING ANOXIA FOR SEVERAL MINUTES, DEBILITATING PAIN, RIGHT LOWER EXTREMITY WEAKNESS, ABSENCE OF REFLEXES IN THE RIGHT LEG, DISC PROTRUSION, STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956621 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC C01A EL25508

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other