BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LXH

    MDR report key: 17023764 · Received May 30, 2023

    Report

    Report Number
    3005739886-2023-00021
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    May 3, 2023
    Report Date
    May 3, 2023
    Manufacturer
    PRECISION SPINE, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3 DEVICE EVALUATION - PRODUCT WAS RECEIVED AND UPON INVESTIGATION WAS CONFIRMED THAT ONE OF THE PRONGS FRACTURED. IT WAS REPORTED THAT THE INSTRUMENT WAS IN THE LOCKED POSITION. ON REVIEW THERE IS MINOR DEFORMATION PRESENT ON THE OUTER SLEEVE COMPONENT; IT IS CLEAR THE DEFORMATION IS APPROXIMATELY MIDLINE. THIS DAMAGE IS POSSIBLE IF THE IMPLANT IS ORIENTATED APPROXIMATELY 45° RELATIVE TO THE INSTRUMENT AXIS. THERE WOULD NEED TO BE SUBSTANTIAL IMPACTION FORCES IN ORDER TO DEFORM THE STEEL OF THE OUTER SHAFT. THE IMPLANT CAN BE LOCKED IN THIS ORIENTATION, BUT THE CURRENT DESIGN ALLOWS FOR A STRESS RISER TO BE PRESENT ORIGINATING AT THE CORNER OF THE INTERNAL OCTAGON, WHICH CORRESPONDS TO THE FRACTURE PRESENT IN THIS COMPLAINT. THIS STRESS RISER IS EXACERBATED BY EXCESSIVE TORQUE ON THE BACK HANDLE WHICH DRAWS THE INNER SHAFT FURTHER IN THE PROXIMAL DIRECTION. DESIGN IMPROVEMENTS WERE IMPLEMENTED (B)(6) 2023. REVIEW OF DEVICE HISTORY RECORDS FOUND TWENTY-EIGHT (28) PIECES OF LOT 27239SF RELEASED FOR DISTRIBUTION ON 1/13/2022 WITH NO DEVIATION OR ANOMALIES. NO ADDITIONAL CORRECTIVE ACTIONS ARE RECOMMENDED.

    Additional Manufacturer Narrative · 0

    H3 OTHER - EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2023, TO EXTEND A COMPETITOR'S CONSTRUCT.. WHILE INSERTING A SHURFIT 3D TITANIUM CURVED INTERBODY CAGE ONE OF THE PRONGS OF THE CURVED CAGE IMPLANT INSERTER (72-IN-1001) BROKE OFF. THE BROKEN PIECE WAS EASILY RETRIEVED AND THE CAGE WAS REMOVED AND A NEW SET WAS OPENED TO OBTAIN A NEW CAGE IMPLANT. THE PROCEDURE WAS THEN COMPLETED UTILIZING ANOTHER INTERBODY FUSION SYSTEM SET. THERE WAS NO PATIEN INJURY REPORTED BUT THERE WAS A 20-30 MINUTE DELAY TO THE PROCEDURE DUE TO THE NEED TO LOCATE AND OPEN ANOTHER INTERBODY FUSION SYSTEM SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2023, TO EXTEND A COMPETITOR'S CONSTRUCT.. WHILE INSERTING A SHURFIT 3D TITANIUM CURVED INTERBODY CAGE ONE OF THE PRONGS OF THE CURVED CAGE IMPLANT INSERTER (72-IN-1001) BROKE OFF. THE BROKEN PIECE WAS EASILY RETRIEVED AND THE CAGE WAS REMOVED AND A NEW SET WAS OPENED TO OBTAIN A NEW CAGE IMPLANT. THE PROCEDURE WAS THEN COMPLETED UTILIZING ANOTHER INTERBODY FUSION SYSTEM SET. THERE WAS NO PATIENT INJURY REPORTED BUT THERE WAS A 20-30 MINUTE DELAY TO THE PROCEDURE DUE TO THE NEED TO LOCATE AND OPEN ANOTHER INTERBODY FUSION SYSTEM SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728081 LXH INSERTER LXH PRECISION SPINE, INC 27239SF

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention