BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 2385217 · Received December 21, 2011

    Report

    Report Number
    2953769-2011-00166
    Event Type
    Injury
    Date Received
    December 21, 2011
    Report Date
    November 30, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT EVENT: AVERAGE AGE WAS (B)(6). SEX: 48% MALES AND 52% FEMALES. EVENTS REPORTED IN THIS ARTICLE ARE REPORTED IN MRF REPORT# 2953769-2011-00166 AND MRF REPORT# 2953769-2011-00167. REPORT SOURCE: ARTICLE TITLED "VERTEBRAL COMPRESSION FRACTURE TREATMENT WITH VERTEBROPLASTY AND KYPHOPLASTY: EXPERIENCE IN 407 PATIENTS WITH 1,156 FRACTURES IN A TERTIARY CANCER CENTER", BY ALLEN W. BURTON, MD, TITO MENDOZA, PHD, RODOLFO GEBHARDT, MD, BASEM HAMID, MD, KENT NOURI, MD, MARCO PEREZ-TORO, MD, JOSEPH TING, DO, AND DHANALAKSHMI KOYYALAGUNTA, MD. EVAL METHOD: FOLLOW-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "VERTEBRAL COMPRESSION FRACTURE TREATMENT WITH VERTEBROPLASTY AND KYPHOPLASTY: EXPERIENCE IN 407 PATIENTS WITH 1,156 FRACTURES IN A TERTIARY CANCER CENTER", A STUDY WAS PERFORMED ON 407 CANCER PATIENTS WITH 1,156 FRACTURES THAT HAD BEEN TREATED WITH VP OR KP DURING 536 SURGICAL PROCEDURES (262 WERE VPS ONLY, 156 WERE KPS ONLY, 111 WERE COMBINED VP/KPS, I.E., A DIFFERENT TECHNIQUE HAD BEEN APPLIED AT DIFFERENT SPINAL LEVELS DURING THE SAME SURGERY, AND 7 WERE SACROPLASTIES. THE FOLLOWING WAS REPORTED IN THE RESULTS. -100 PATIENTS (24%) HAD EXPERIENCED 259 NEW FRACTURES (I.E., FRACTURES SUBSEQUENT TO A PREVIOUS PROCEDURE). OF THE NEW FRACTURES, 119 (46%) HAD OCCURRED AT A LEVEL ADJACENT TO PREVIOUSLY CEMENTED FRACTURES. FIFTY OF THE 78 PATIENTS WHO HAD UNDERGONE TWO PROCEDURES, AND ALL OF THE PATIENTS WHO HAD UNDERGONE THREE, FOUR, OR FIVE PROCEDURES, HAD BEEN TREATED FOR ADJACENT-LEVEL FRACTURES. -PAIN AND SYMPTOM DATA WERE UNAVAILABLE FOR 237 PATIENTS (58%). PAIN AND SYMPTOM SCORES WERE AVAILABLE FOR A FOLLOW-UP PERIOD OF UP TO 60 DAYS. NINETEEN PERCENT OF THE RESPONDENTS REPORTED AN INCREASE IN PAIN, 22% NO CHANGE, AND 59% LESS PAIN. -OF THE SEVEN NON-EXTRUSION COMPLICATIONS, SYMPTOMATIC EPIDURAL EXTRAVASATION WAS EXPERIENCED BY FOUR PATIENTS, TWO OF WHOM REQUIRED OPEN-SURGERY DECOMPRESSION FOR MILD WEAKNESS THAT RESULTED IN SYMPTOMATIC RESOLUTION. MILDLY INCREASED PAIN AND RADICULAR SYMPTOMS WERE NOTED FOR TWO PATIENTS, WHO DID WELL WITH CONSERVATIVE MANAGEMENT. -A FINAL PATIENT WITH SIGNIFICANT COMORBIDITIES, INCLUDING MORBID OBESITY AND DIABETES, DEVELOPED VERTEBRAL BODY INFECTION THAT WAS SUBSEQUENTLY TREATED SUCCESSFULLY. NO FURTHER INFORMATION WAS REPORTED. NOTE: THE ARTICLE DID NOT DISCUSS OR INCLUDE ANY APPLICABLE DEVICES OR PRODUCTS. PMMA WAS INDICATED AS THE CEMENT INJECTED. PER FOLLOW-UP, THE AUTHOR STATED THAT ABOUT HALF OF THE PATIENTS HAD KYPHOPLASTY USING MDT/KYPHON PRODUCTS, AND THE OTHER HALF HAD VERTEBROPLASTY USING OTHER EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPE HRX MEDTRONIC SPINE LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Other