BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 2385220 · Received December 21, 2011

    Report

    Report Number
    2953769-2011-00167
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Report Date
    November 30, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EVENTS REPORTED IN THIS ARTICLE ARE REPORTED IN MFR 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. 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. -THE VAST MAJORITY OF THE COMPLICATIONS WERE ASYMPTOMATIC CEMENT EXTRUSIONS. OF THE 134 COMPLICATIONS THAT HAD BEEN NOTED, PARAVERTEBRAL CEMENT SPREAD WAS THE MOST PREVALENT (38.8%, N = 52) AND WAS FOLLOWED BY INTRADISCAL EXTRUSION (28.4%, N = 38), VENOUS EXTRUSION (23.9%, N = 32), EPIDURAL EXTRUSION (3.7%, N = 5), AND OTHERS (5.2%; N = 7). 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