BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW 7X50

    MDR report key: 7292581 · Received February 23, 2018

    Report

    Report Number
    3005180920-2018-00097
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    January 25, 2018
    Report Date
    February 23, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030834301
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED ON 23 FEBRUARY 2018 BY MEDICAL AFFAIRS DIRECTOR: SET SCREWS FRACTURE IN A THREE-LEVEL LUMBAR FUSION EXTENDING DOWN TO S1. FROM THE XRAYS WE ARE UNABLE TO DETERMINE WHICH SCREWS ARE FRACTURED. ACCORDING TO REPORT, THE CAUSE FOR REVISION WAS SCREW LOOSENING. THE TIME WHEN THE SCREWS BROKE WAS NOT DETERMINED. WE ARE UNABLE TO DRAW CONCLUSIONS ON THIS CASE WITH THE ELEMENTS AT HAND. PRELIMINARY INVESTIGATION PERFORMED BY R AND D PRODUCT MANAGER ON 23 FEBRUARY 2018: REVISION SURGERY DUE TO PSEUDO ARTHROSIS AFTER 9 MONTHS FROM THE FIRST SURGERY. PSEUDO ARTHROSIS IS A TYPICAL LONG TERM FAILURE OF A SPINAL FIXATION CONSTRUCT, IN CASE OF DELAYED FUSION, SCREW LOOSENING OR SPINAL CONSTRUCT INSTABILITY, WHICH MIGHT BE CAUSED BY A NUMBER OF NON-DEVICE-RELATED CAUSES. DURING THE INTERVENTION THE SURGEON FOUNT 3 SET SCREWS BROKEN. THE PICTURES RECEIVED DON'T ALLOW TO CLEARLY IDENTIFY THE BREAKAGE OF THE SET SCREWS, NOR TO DEFINE WHITER THE BREAKAGE OCCURRED DURING THE SURGERY (PRIMARY OR REVISION) OR DURING THE PERMANENCE OF THE IMPLANT IN THE PATIENT. THE SET SCREWS ARE MADE IN STANDARD MATERIAL FOR THIS APPLICATIONS. IN CASE OF PSEUDO ARTHROSIS, THE SPINAL CONSTRUCT IS SUBJECT TO ABNORMAL HIGH FORCES FOR LONG TERM, WHICH MIGHT LEAD TO BREAKAGE OF THE MOST STRESSED COMPONENTS: SCREW SHAFT OR SPINAL ROD. FRACTURE OF THE SET SCREW IS AN UNLIKELY EVENT AND MIGHT BE CAUSED TO ATYPICAL FORCES/MANEUVERS APPLIED DURING THE PRIMARY SURGERY, OR TO A SPECIFIC EVENT SUCH AS A TRAUMA. BATCH REVIEW PERFORMED ON 23 FEBRUARY 2018 (B)(4). PEDICLE SCREW 7X40 REFERENCE 03.50.030 (K121115) (B)(4). PEDICLE SCREW 7X40 REFERENCE 03.50.030 (K121115) (B)(4). PEDICLE SCREW 7X45 REFERENCE 03.50.031 (K121115) (B)(4). PEDICLE SCREW 7X45 REFERENCE 03.50.031 (K121115) (B)(4). PEDICLE SCREW 7X45 REFERENCE 03.50.031 (K121115) (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CAME IN FOR A REVISION OF A POSTERIOR FUSION OF L3-S1, 9 MONTHS AFTER PRIMARY. THE SCREWS WERE LOOSE. THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE SCREWS AND RODS. AFTER THE CASE THE AGENT NOTICED THAT 3 SET SCREWS OF THE L3-L4 SCREW WERE BROKEN. IT IS UNKNOWN IF THE SCREWS BROKE WHILE IN THE PATIENT OR UPON REMOVAL. THE SURGEON IMPLANTED ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. FUSION WAS ACHIEVED IN 2 VERTEBRA YET NOT ACHIEVED AT L5-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134783 PEDICLE SCREW 7X50 PEDICLE SCREW KWP MEDACTA INTERNATIONAL SA 165260 07630030834301

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention