BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW 03.50.403 ROD TI 5.5X480

    MDR report key: 12786545 · Received November 10, 2021

    Report

    Report Number
    3005180920-2021-00866
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    October 11, 2021
    Report Date
    November 10, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030835360
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 OCTOBER 2021: LOT 1821287: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2019. EXPIRATION DATE: 2024-01-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 2 YEARS AFTER DEFORMITY REDUCTION SURGERY IN AN ADOLESCENT PATIENT, ONE OF THE RODS, IN A REGION NOT SUPPORTED BY PEDICLE SCREWS, BROKE. ACCORDING TO REPORT, THE PATIENT WAS DOING REGULAR WORKOUT EXERCISES, AND THIS MAY HAVE SUBJECTED THE IMPLANTS TO EXCESSIVE STRESS, PARTICULARLY IN THE UNSUPPORTED AREA, THAT REQUIRED ADDITIONAL SCREWS AND A NEW ROD. DIRECT ANALYSIS TO VERIFY THAT NO DEFECT WAS PRESENT IN THE ROD WOULD HAVE BEEN ADVISABLE, BUT ACCORDING TO REPORT THE ROD IS NOT AVAILABLE. A REASONABLE EXPLANATION FOR THE FRACTURE OF A DEFECT-FREE ROD IS AVAILABLE AS DETAILED ABOVE. PATIENT MATCH PLANNING REVIEW: 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 X-RAYS REVEALED THAT THE ROD WAS BROKEN. THE SURGEON HAD TO REMOVE THE ROD AND 3 SCREWS 2 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT IN ANY PAIN ONCE THE ROD BROKE. THE PATIENT WAS WORKING OUT 2-3 TIMES A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687594 PEDICLE SCREW 03.50.403 ROD TI 5.5X480 SPINE PEDICLE SCREW KWP MEDACTA INTERNATIONAL SA 03.50.403 1821287 07630030835360

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Other