BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSPINE SCREW, UNKNOWN SIZE

    MDR report key: 8770917 · Received July 9, 2019

    Report

    Report Number
    3004788213-2019-00205
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    April 17, 2019
    Report Date
    July 20, 2020
    Manufacturer
    LDR MÉDICAL
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D2 (COMMON DEVICE NAME): EASYSPINE SYSTEM OR LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S. G5 (PMA/510K): K121103 OR K123134. CORRECTION TO: A1, B2, B5, B6, B7, D1, D2 (COMMON DEVICE NAME), E1 (FIRST NAME, MIDDLE NAME), E3, G5 (PMA/510K), H3, H6 (PATIENT CODE AND DEVICE CODE). ADDITIONAL INFORMATION: D4 (UDI NUMBER), D10, H6 (RESULTS AND CONCLUSION CODES). THE SCREW WAS NOT RETURNED FOR EVALUATION, SO NO RESULTS ARE AVAILABLE AND NO CONCLUSIONS CAN BE DRAWN. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR UNKNOWN REASONS IN WHICH AN EASYSPINE SCREW WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS SUBMITTED TO SEND THE INITIAL REPORT OF THIS COMPLAINT. REFERENCE AND LOT NUMBER OF CONCERNED DEVICE ARE NOT KNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE AND NO ANSWER HAS BEEN PROVIDED YET. SO FAR, IS NOT POSSIBLE TO PERFORM THE REVIEW OF TRACEABILITY AND DEVICES HISTORY RECORDS. PRODUCT WAS NOT RETURNED YET, NO EVALUATION COULD BE PERFORMED. INVESTIGATION STILL IN PROGRESS. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    EASYSPINE : REVISION SURGERY, UNKNOWN REASON. ON (B)(6) IT WAS REPORTED THAT A REVISION WAS PERFORMED. SURGICAL TECHNIQUE WAS FOLLOWED. NO PATIENT OR SURGERY IMPACT. NO MORE INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED. INVESTIGATION ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564446 EASYSPINE SCREW, UNKNOWN SIZE SEE H10 NKB LDR MÉDICAL N/A NO INFORMATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R