BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER SPINE AERO C

    MDR report key: 7063448 · Received November 28, 2017

    Report

    Report Number
    MW5073583
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    April 6, 2016
    Report Date
    July 30, 2018
    Manufacturer
    STRYKER SPINE
    Product Code
    ODP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON 07/30/2018 FOR REPORT NUMBER MW5073583. REPORTER STATED SHE WAS IMPLANTED ON (B)(6) 2017 WITH TWO DEVICES BY DEPUY / SYNTHES; A ROD MODEL #04614730, 30MM AND A SKYLINE PLATE 1 LEVEL, 14MM, TI, #186801014 WITH SCREW # 186850014. RIGHT AFTER THE IMPLANTS, SHE STARTED TO EXPERIENCE PAIN. SHE CALLED THE MFR TO REPORT THE INCIDENCE AND WAS TOLD THAT A REPORT WILL BE FILED TO FDA ON HER BEHALF AND SHE NEVER HEARD FROM THEM AGAIN. SINCE THE IMPLANTS SHE'S BEEN TRYING TO FIND HELP FROM DRS AND NOBODY WILL HELP. IN (B)(6) 2018 SHE HAD A CAT SCAN WHICH SHOWS THAT THE SCREWS IN HER NECK ARE LOOSE AND POPPED OUT AND ARE NO LONGER SECURED. DURING THE SAME SCAN, THE IMAGES ALSO SHOWS THAT HER VERTEBRAL HAD FRACTURED AND THE SCREWS ARE THE CAUSE. SHE WAS ADVISED BY A DR TO DO SOMETHING BECAUSE THE FRACTURE CAN LEAD TO PARALYSIS. IT WAS ALSO OBSERVED THAT THE BONES NEVER FUSED TOGETHER. SHE SAID SHE'S BEEN GOING FROM ONE PROBLEM TO ANOTHER AND HAS NO HELP TO SOLVE ANY OF THEM. NOW SHE IS BEEN FORCED TO GO TO (B)(6) FOR FURTHER CONSULTATION. REF REPORT NUMBERS: MW5071558, MW5072144, AND MW5072144-1.

    Description of Event or Problem · 1

    I WAS IMPLANTED WITH STRYKER SPINE AERO-C WHICH STUCK OUT 3MM INTO MY ESOPHAGUS CAUSING DAMAGE TO IT UNABLE TO EAT CAUSED A REVISION SURGERY. REFERENCE REPORT NUMBERS MW5071558,MW5072144, AND MW5072144-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841991 STRYKER SPINE AERO C AERO - C CERVICAL CAGE SYSTEM ODP STRYKER SPINE

    Patients

    Seq Age Sex Outcome Treatment
    0 37 YR Other| R