BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE CLAMP FOR SPINE NAVIGATION PACKAGE

    MDR report key: 6211498 · Received December 28, 2016

    Report

    Report Number
    0001811755-2016-02920
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    May 13, 2013
    Report Date
    March 7, 2017
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K012380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL PROCEDURE UTILIZING A STRYKER NAVIGATION SYSTEM, STRYKER SPINE CLAMP, STRYKER SPINEMAP SOFTWARE, STRYKER XIA CANNULATED PROBE, STRYKER ES2 SPINAL SYSTEM AND A SIEMENS ORBIC C-ARM THE SPINE CLAMP WAS THOUGHT TO HAVE BEEN BUMPED, CAUSING THE SYSTEM AND SOFTWARE TO BECOME INACCURATE, RESULTING IN THE INACCURATE PLACEMENT OF 4 SCREWS. AT THE COMPLETION OF THE PROCEDURE, A SPIN WAS TAKEN WITH THE SIEMENS ORBIC C-ARM, AT WHICH TIME THE SCREWS WERE IDENTIFIED TO HAVE BEEN INACCURATELY PLACED. THE SURGEON REMOVED THE SCREWS AND CLOSED. IT WAS FURTHER REPORTED THAT A REVISION SURGERY WAS COMPLETED APPROXIMATELY ONE WEEK LATER TO PLACE THE SCREWS AND WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING FOOT DROP, BUT NO FURTHER INFORMATION REGARDING THE PATIENT¿S OUTCOME WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL PROCEDURE UTILIZING A STRYKER NAVIGATION SYSTEM, STRYKER SPINE CLAMP, STRYKER SPINEMAP SOFTWARE, STRYKER XIA CANNULATED PROBE, STRYKER ES2 SPINAL SYSTEM AND A SIEMENS ORBIC C-ARM THE SPINE CLAMP WAS THOUGHT TO HAVE BEEN BUMPED, CAUSING THE SYSTEM AND SOFTWARE TO BECOME INACCURATE, RESULTING IN THE INACCURATE PLACEMENT OF 4 SCREWS. AT THE COMPLETION OF THE PROCEDURE, A SPIN WAS TAKEN WITH THE SIEMENS ORBIC C-ARM, AT WHICH TIME THE SCREWS WERE IDENTIFIED TO HAVE BEEN INACCURATELY PLACED. THE SURGEON REMOVED THE SCREWS AND CLOSED. IT WAS FURTHER REPORTED THAT A REVISION SURGERY WAS COMPLETED APPROXIMATELY ONE WEEK LATER TO PLACE THE SCREWS AND WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING FOOT DROP, BUT NO FURTHER INFORMATION REGARDING THE PATIENT¿S OUTCOME WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL PROCEDURE UTILIZING A STRYKER NAVIGATION SYSTEM, STRYKER SPINE CLAMP, STRYKER SPINEMAP SOFTWARE, STRYKER XIA CANNULATED PROBE, STRYKER ES2 SPINAL SYSTEM AND A SIEMENS ORBIC C-ARM THE SPINE CLAMP WAS THOUGHT TO HAVE BEEN BUMPED, CAUSING THE SYSTEM AND SOFTWARE TO BECOME INACCURATE, RESULTING IN THE INACCURATE PLACEMENT OF 4 SCREWS. AT THE COMPLETION OF THE PROCEDURE, A SPIN WAS TAKEN WITH THE SIEMENS ORBIC C-ARM, AT WHICH TIME THE SCREWS WERE IDENTIFIED TO HAVE BEEN INACCURATELY PLACED. THE SURGEON REMOVED THE SCREWS AND CLOSED. IT WAS FURTHER REPORTED THAT A REVISION SURGERY WAS COMPLETED APPROXIMATELY ONE WEEK LATER TO PLACE THE SCREWS AND WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING FOOT DROP, BUT NO FURTHER INFORMATION REGARDING THE PATIENT¿S OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858790 SPINE CLAMP FOR SPINE NAVIGATION PACKAGE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ES2 SPINE SYSTEM (MIES2ST13031SSP, SN: UNK)| SIEMENS ORBIC C-ARM (UNK CATALOG & SN)| SPINEMAP 3D 2.0 SOFTWARE (6002-660-000, SN:UNK)| STRYKER NAVIGATION SYSTEM (6000115000, SN: UNK)| XIA CANNULATED PROBE (42105002SSP, SN: UNK)