BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW MUST MC Ø6X35

    MDR report key: 17116003 · Received June 13, 2023

    Report

    Report Number
    3005180920-2023-00416
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    May 16, 2023
    Report Date
    June 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971294851
    PMA / PMN Number
    K210427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 MAY 2023LOT 2222516: 30 ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2022. EXPIRATION DATE: 2027-MAY-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 26 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.MYSOLUTION PLANNING ANALYSIS:OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED FROM X-RAYS THAT A SCREW HAD BECOME MISPLACED. AT 5 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON REDIRECTED THE SCREW, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. FLUOROSCOPY WAS USED DURING THE PRIMARY. THE SCREW WAS LIKELY MALPOSITIONED DURING THE PRIMARY SURGERY. NO ISSUE WITH THE MYSPINE GUIDES OCCURRED DURING THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248292 PEDICLE SCREW MUST MC Ø6X35 SPINE PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.58.443 2222516 07630971294851

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention