BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLOFUSE CORTICAL CERVICAL SPACERS

    MDR report key: 8353440 · Received February 20, 2019

    Report

    Report Number
    8353440
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    November 27, 2018
    Report Date
    February 14, 2019
    Manufacturer
    ALLOSOURCE INC
    Product Code
    MQV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER DISCHARGE THE PHYSICIAN DISCOVERED THE FRACTURE ON A POST OP X-RAY. PHYSICIAN HAS USED THE 4521 SERIES OF CERVICAL SPACERS FOR YEARS. OVER THE LAST YEAR HE HAS NOW HAD 3 SPACER FRACTURES SHOWN ON POST OP X-RAY CHECKS. THE 3 SURGERIES WERE WITHIN THE LAST 12 MONTHS. HE IS NOT GOING TO CONTINUE USING THEM. HE HAS APPLIED BONE STIMULATORS TO PROMOTE FUSION AND HOPES THAT HE DOES NOT HAVE TO RE-OPERATE. THE PHYSICIAN STATED THERE WAS A GOOD CHANCE THAT ONE OF THE PATIENTS WILL HAVE A REVISION DIRECTLY RELATED TO THE SPACER FAILURE. MANUFACTURER RESPONSE FOR ALLOFUSE CORTICAL CERVICAL SPACERS, (BRAND NOT PROVIDED) (PER SITE REPORTER). THE (B)(4) AREA MANAGER FOR ALLOSOURCE STATED IN HIS EMAIL, "IDEALLY, THE CONVERSATION WITH [THE PHYSICIAN] TAKES PLACE WITH OUR MEDICAL DIRECTOR, DR. (B)(6). THE PEER TO PEER DIALOG DUE TO THE SEVERITY OF THIS SITUATION CALLS FOR THIS ESCALATED DIALOG." THE (B)(4) AREA MANAGER SAID THAT ONCE HE KNOWS WHEN THE PHYSICIAN IS AVAILABLE, HE WILL FACILITATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147463 ALLOFUSE CORTICAL CERVICAL SPACERS ALLOFUSE CORTICAL CERVICAL SPACERS MQV ALLOSOURCE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA