BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC POSTERIOR SPINAL FIXATION SYSTEM

    MDR report key: 14310089 · Received May 6, 2022

    Report

    Report Number
    3015941638-2022-00001
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    July 6, 2020
    Report Date
    February 17, 2022
    Manufacturer
    ASTURA MEDICAL
    Product Code
    NKB
    UDI-DI
    00841379131212
    PMA / PMN Number
    K153466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS ORIGINALLY REPORTED ON (B)(6) 2020. OUR INITIAL INVESTIGATION LED TO THE CONCLUSION THAT A MDR WAS NOT WARRANTED. HOWEVER, AFTER A 3RD PARTY AUDIT OF OUR QUALITY SYSTEM IT WAS IDENTIFIED THAT THIS EVENT IS SHOULD BE REPORTED DUE TO THE SURGICAL INTERVENTION THAT WAS PERFORMED. A CAPA WAS CREATED TO REVIEW OUR INVESTIGATION PROCESS AND UPDATE THE RELEVANT SOP DOCUMENTS. OLDER FEEDBACK INVESTIGATIONS WERE REVIEWED TO DETERMINE IF ANY WARRANT A MDR. IN RESPONSE TO THE AUDIT AND CAPA, THIS MDR IS BEING SUBMITTED RETROACTIVLY PER OUR UPDATED GUIDELINES.

    Description of Event or Problem · 0

    PATIENT HAD A SPINAL FUSION SURGERY PERFORMED ON (B)(6) 2020. DURING A FOLLOW-UP IT WAS OBSERVED THAT SOME OF THE LOCKING SET SCREWS HAD BECOME DISLODGED FROM THE PEDICLE SCREWS. A REVISION SURGERY WAS PERFORMED TO REPLACE THE LOCKING SCREWS. NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889463 OLYMPIC POSTERIOR SPINAL FIXATION SYSTEM PEDICLE SCREW SYSTEM NKB ASTURA MEDICAL ABAA00055 421101G 00841379131212

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention