BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 2830114 · Received November 13, 2012

    Report

    Report Number
    2953769-2012-00162
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: SANG-BUM AN, JIYEON YIM, EUNJUNG KIM, JAE-HYUCK SHIN, SOO YOUNG PARK, AND SANG CHUL LEE. ACUTE CHOLECYSTITIS DEVELOPED IMMEDIATELY AFTER THORACIC KYPHOPLASTY. KOREAN JOURNAL OF ANESTHESIOLOGY 2012; SEPTEMBER 63(3): 266-269. ALTHOUGH IT IS UNKNOWN IF THE PROCEDURE OR DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. DATE OF EVENT IS UNKNOWN. (B)(4). MEDICAL JUDGMENT CONCLUSION "PATIENT UNDERWENT KYPHOPLASTY AT T12 AND DEVELOPED FEVER, CHILLS THE FOLLOWING MORNING APPROXIMATELY 12-18 HOURS POSTOP. CBC, ESR AND CRP VERIFIED ACUTE CHOLECYSTITIS. CT VERIFIED GANGRENOUS GALLBLADDER WITH LIVER ABCESSES. LIKELY THE PROCESS BEGAN PRIOR TO KYPHOPLASTY TIMELINE (>48 HRS) AND THEREFORE WAS NOT CAUSED BY THE PROCEDURE, BUT TIMING OF FLAIR-UP COULD HAVE BEEN INFLUENCED BY FASTING AND ANESTHESIA."

    Description of Event or Problem · 1

    IT WAS REPORTED IN A CASE STUDY THAT A PATIENT ORIGINALLY PRESENTED WITH SYMPTOMS OF LOW BACK PAIN DUE TO A SLIP-DOWN INJURY THAT OCCURRED ONE MONTH PRIOR. THE PAIN WAS "INTRACTABLE TO CONSERVATIVE TREATMENT AND INCREASED WITH ANY MOVEMENT." ACCORDING TO THE REPORT, X-RAY AND MRI IMAGES REVEALED A NEWLY DEVELOPED COMPRESSION FRACTURE AT THE T12 VERTEBRAL BODY WITH LOSS OF HEIGHT, LEADING TO KYPHOSIS. BALLOON KYPHOPLASTY WAS PERFORMED AND COMPLETED WITHOUT INCIDENT AND THE PATIENT'S PAIN INTENSITY REPORTEDLY DECREASED IMMEDIATELY AFTER THE KYPHOPLASTY. ACCORDING TO THE REPORT, ON DAY 1 POST-OP, THE PATIENT "FELT A CHILLING SENSATION AND INTERMITTENT SWEATING WITH A FEVER UP TO 39 DEGREES C" AND ALSO COMPLAINED OF VAGUE WHOLE ABDOMEN DISCOMFORT. ACCORDING TO THE REPORT, THERE WAS NO SIGN OF SKIN INFECTION AT THE SITE OF KYPHOPLASTY, NO REFERRED PAIN, OR NEUROLOGIC DEFICIT ALONG THE DERMATOME OF T12 SOMATOSENSORY LEVEL. PHYSICAL EXAM LATER THE SAME DAY REVEALED THAT THE PATIENT HAD PAIN IN THE RIGHT UPPER QUADRANT REVEALING POSITIVE MURPHY'S SIGN. AN ABDOMINAL CT SCAN WAS TAKEN AND SHOWED EVIDENCE OF ACUTE CHOLECYSTITIS AND MULTIPLE LIVER MICRO-ABSCESSES. EMERGENCY PERCUTANEOUS TRANSHEPATIC GALLBLADDER DRAINAGE (PTGBD) WAS CARRIED OUT AND THE PATIENT WAS TREATED WITH ANALGESICS AND ANTIBIOTICS. ACCORDING TO THE REPORT, SYMPTOMS GRADUALLY SUBSIDED OVER 3 WEEKS AND THE PATIENT WAS DISCHARGED WITHOUT ANY FURTHER COMPLICATIONS. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPE HRX MDT KYPHON SUNNYVALE MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention