BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSPINE SCREW, UNKOWN SIZE OR TYPE

    MDR report key: 10418051 · Received August 17, 2020

    Report

    Report Number
    3004788213-2020-00116
    Event Type
    Injury
    Date Received
    August 17, 2020
    Date of Event
    April 8, 2019
    Report Date
    August 17, 2020
    Manufacturer
    LDR MEDICAL
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TYPE OF THE DEVICE: COMMON DEVICE NAME: LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S OR EASYSPINE SYSTEM. PMA/510(K) NUMBER: K123134 OR K121103. THE PRODUCT WAS NOT RETURNED AND NO PHOTOS, INTRA-OP/POST-OP IMAGES, OR SURGICAL NOTES WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. AS SUCH, NO EVALUATION RESULTS ARE AVAILABLE AND NO CONCLUSIONS REGARDING THE CAUSE CAN BE DRAWN. THE LOT NUMBER WAS NOT PROVIDED, SO THE DHR IS UNABLE TO BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE A SCREW FOR UNKNOWN REASONS. THERE WAS NO FURTHER SURGICAL OR PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878253 EASYSPINE SCREW, UNKOWN SIZE OR TYPE SEE H10 NKB LDR MEDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R