BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW PEDICLE SCREW 6X40

    MDR report key: 7897546 · Received September 21, 2018

    Report

    Report Number
    3005180920-2018-00717
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    August 24, 2018
    Report Date
    September 21, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030834202
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2018; LOT 1721184: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 FEBRUARY 2018. EXPIRATION DATE: 2023-01-21; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT SIMILAR REPORTED EVENT OTHER DEVICS INVOLVED: REFERENCE 03.50.017 (K121115) PEDICLE SCREW 6X40; LOT 1721174: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 FEBRUARY 2018 EXPIRATION DATE: 2022-11-16; 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. REFERENCE 03.50.017 (K121115) PEDICLE SCREW 6X40; LOT 147482: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 NOVEMBER 2014. EXPIRATION DATE: 2019-10-22; 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. MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X9 L5° REFERENCE 03.27.007 (K133192); LOT 1720715: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MAY 2018. EXPIRATION DATE: 2023-04-19; 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 (B)(4) ON 21 SEPTEMBER 2018; LUMBAR L4-L5 FUSION WITH PLIF CAGE AND PEDICLE SCREWS. ACCORDING TO REPORT, ONE OF THE 4 SET SCREWS LOOSENED AFTER FEW DAYS. ALSO THE CAGE WAS FOUND TO HAVE MIGRATED. WE CANNOT IMAGINE A CLINICAL CAUSE FOR THE LOOSENING OF THE SCREW AFTER SUCH A SHORT TIME. ONE POSSIBILITY COULD BE TECHNICAL ERROR BUT WE HAVE NO EVIDENCE IN EITHER SENSE. FROM THE CLINICAL POINT OF VIEW, THE CAUSE CANNOT BE DETERMINED. VISUAL INSPECTION PERFORMED ON SEPTEMBER THE 19TH, 2018 BY R&D PRODUCT MANAGER THE IMPLANT, REF. 03.27.007, LOT 1720715 ANALIZED, IS ACCORDING TO THE SPECIFICATION FOR WHICH CONCERN DIMENSIONS AND MATERIAL. THERE ARE SMALL SCRATCHES ON THE COATING SURFACE PROBABLY DUE TO THE REMOVAL OPERATION, SEE PICTURES ENCLOSED. QUALITY CONTROL DEPARTMENT INSPECTED THE RETURNED TORQUE LIMITER, NO ANOMALIES FOUND. PIECE IS CONFORMING TO SPECIFICATION.

    Description of Event or Problem · 1

    THE PATIENT ALLEGED PAIN AND ABNORMAL FEELING A WEEK AFTER PRIMARY SURGERY (PLIF DUE TO L4 SPONDYLOLISTHESIS) . THE SURGEON CONFIRMED THAT THE CAGE MIGRATED. REVISION SURGERY PERFORMED TWO WEEKS AFTER THE PRIMARY AND THE SURGEON CONFIRMED THE SET SCREW AT L5 LEFT SIDE LOOSEN. THE SURGEON REPLACED THE CAGE AND ALL SET SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739315 PEDICLE SCREW PEDICLE SCREW 6X40 PEDICLE SCREW KWP MEDACTA INTERNATIONAL SA 1721184 07630030834202

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention