BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM

    MDR report key: 17403723 · Received July 27, 2023

    Report

    Report Number
    3005180920-2023-00564
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    June 28, 2023
    Report Date
    August 29, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030857577
    PMA / PMN Number
    K141988
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 JULY 2023: LOT 2127950: 70 ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2022. EXPIRATION DATE: 2027-01-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 48 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INFO RECEIVED BATCH REVIEW PERFORMED ON 10 JULY 2023: PEDICLE SCREW 03.52.323 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM (K141988) LOT 2229810: 100 ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2023. EXPIRATION DATE: 2028-01-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 59 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    ON THE 3RD OF AUGUST, 2023 WE HAVE RECEIVED THE ITEMS INVOLVED IN THE EVENT. VISUAL INSPECTION PERFORMED BY R&D MANAGER: AS REPORTED IN ADDITIONAL INFORMATION RECEIVED, TAPPING WAS PERFORMED USING REF (B)(4). THESE TAPS HAVE AN OUTER NOMINAL DIAMETER OF 5 AND 6MM, RESPECTIVELY. THE ACTUAL DIAMETER IS UNDERSIZED -0.5MM FOR BOTH TAPS, LEADING IT TO Ø4.5 AND Ø5.5MM. THE MARKING ON THE TAPS CLEARLY INDICATES THE UNDERSIZING AND THE AMOUNT; FOR REF. (B)(4), FOR EXAMPLE, IT IS MARKED: "TAP Ø6 MM - UNDERSIZED 0.5 MM". THIS CONFIRMS THE STATEMENT REPORTED IN THE EVENT DESCRIPTION:"...THE DIAMETER OF THE HOLE CREATED BY 6MM TAPPING IS SLIGHTLY SMALLER THAN 6MM, SO THE HOLE WILL BE WIDENED WITH A SCREW." Ø5.5 SCREW IS NOT AVAILABLE IN MUST 2 LEAD PORTFOLIO, BUT ONLY FOR MUST MC 4 LEAD SCREW.

    Description of Event or Problem · 0

    L4/5 PLIF PRIMARY SURGERY WAS CONDUCTED WITH COMPETITOR'S PRODUCTS IN 2013. DURING REVISION SURGERY OF COMPETITOR'S IMPLANT (5.5MM SCREWS) DUE TO ADJACENT INTERVERTEBRAL OBSTRUCTION, AFTER INSERTION OF 6X35MM SCREW IN LEFT SIDE AND 6X40MM SCREW IN RIGHT SIDE, PATIENT'S VERTEBRAE FRACTURE WAS NOTICED. BOTH OF SCREWS IN RIGHT AND LEFT SIDE WERE REMOVED. THE CAUSE OF FRACTURE WAS UNKNOWN. 6MM TAPPING WAS PERFORMED IN L5 RIGHT AND LEFT. THE SURGEON TRIED TO INSERT NEW 6X30MM SCREW IN L5 RIGHT SIDE, BUT THE BLEEDING OCCURRED AND THE SCREW WAS REMOVED. NO SCREW WAS IMPLANTED IN BOTH SIDE OF L5, A ROD WAS IMPLANTED BETWEEN L3/4 ONLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    L4/5 PLIF PRIMARY SURGERY WAS CONDUCTED WITH COMPETITOR'S PRODUCTS IN 2013. DURING REVISION SURGERY OF COMPETITOR'S IMPLANT (5.5MM SCREWS) DUE TO ADJACEMENT INTERVERTEBRAL OBSTRUCTION, AFTER INSERTION OF 6X35MM SCREW IN LEFT SIDE AND 6X40MM SCREW IN RIGHT SIDE, PATIENT'S VERTEBRAE FRACTURE WAS NOTICED. BOTH OF SCREWS IN RIGHT AND LEFT SIDE WERE REMOVED. THE CAUSE OF FRACTURE WAS UNKNOWN. 6 MM TAPPING WAS PERFORMED IN L5 RIGHT AND LEFT. THE TAPS USED IN THE SURGERY WERE REF. 03.51.10.0239 AND 03.51.10.0240. THE DIAMETER OF THE HOLE CREATED BY 6MM TAPPING IS SLIGHTLY SMALLER THAN 6MM, SO THE HOLE WILL BE WIDENED WITH A SCREW. THE SURGEON TRIED TO INSERT NEW 6X30MM SCREW IN L5 RIGHT SIDE, BUT THE BLEEDING OCCURRED AND THE SCREW WAS REMOVED. NO SCREW WAS IMPLANTED IN BOTH SIDE OF L5, A ROD WAS IMPLANTED BETWEEN L3/4 ONLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323761 PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 2127950 07630030857577

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other