BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSTERIOR CERVICAL SCREW, MANUFACTURER UNKNOWN

    MDR report key: 10164111 · Received June 17, 2020

    Report

    Report Number
    0009617544-2020-00090
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Date of Event
    May 21, 2020
    Report Date
    August 28, 2020
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    STRYKER MARKETING EMPLOYEE BECAME AWARE OF X-RAYS SHOWING SPINE HARDWARE FAILURE THROUGH A FACEBOOK GROUP. MULTIPLE ATTEMPTS WERE MADE TO IDENTIFY WHAT DEVICES WERE IMPLANTED AND ANY ADDITIONAL INFORMATION REGARDING THE EVENT HOWEVER NO RESPONSE WAS RECEIVED. WE ARE NOT ABLE TO CONFIRM AT THIS TIME IF ANY OF THE IMPLANTS WERE MANUFACTURED BY STRYKER. IT IS UNKNOWN IF THE PATIENT WAS HARMED AS A RESULT OF THIS INCIDENT. THE X-RAYS WERE EVALUATED BY STRYKER CHIEF MEDICAL OFFICER WHO CONCLUDED: THE PATIENT APPEARS TO HAVE BEEN IMPLANTED WITH A PLATE ON THE ANTERIOR SURFACE OF THE CERVICAL SPINE AND WITH SCREWS AND RODS ON THE POSTERIOR SURFACE OF THE CERVICAL SPINE. THE DEVICES ARE INTACT. HOWEVER, IT APPEARS THAT THE PROXIMAL SCREWS IN THE POSTERIOR CERVICAL SPINE HAVE PULLED OUT, A KYPHOTIC DEFORMITY HAS OCCURRED, AND THE PROXIMAL SCREWS IN THE ANTERIOR PLATE HAVE MIGRATED AND THE STRUT GRAFT DISLODGED. THE FAILURE OF THE SURGERY MAY BE DUE TO NUMEROUS FACTORS: INJURY POSTOPERATIVELY SUCH AS A FALL, POOR SURGICAL TECHNIQUE AND JUDGEMENT, POOR BONE QUALITY, FAILURE OF POST OPERATIVE IMMOBILIZATION. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED CONCLUSIVELY AS INSUFFICIENT INFORMATION WAS PROVIDED TO STRYKER. FURTHERMORE, IT CANNOT BE DETERMINED IF IMPLANTED DEVICES WERE MANUFACTURED BY STRYKER THEREFORE NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED AND UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH SOCIAL MEDIA THAT AN UNIDENTIFIED PATIENT EXPERIENCED AN UNKNOWN EVENT INVOLVING DEVICES MADE BY AN UNIDENTIFIED MANUFACTURER. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. THE PATIENT APPEARS TO HAVE BEEN IMPLANTED WITH A PLATE ON THE ANTERIOR SURFACE OF THE CERVICAL SPINE AND WITH SCREWS AND RODS ON THE POSTERIOR SURFACE OF THE CERVICAL SPINE. UPON PROFESSIONAL REVIEW OF THE POSTED X-RAY, IT HAS BEEN DETERMINED THAT THE DEVICES ARE INTACT. HOWEVER, IT APPEARS THAT THE PROXIMAL SCREWS IN THE POSTERIOR CERVICAL SPINE HAVE PULLED OUT, A KYPHOTIC DEFORMITY HAS OCCURRED, AND THE PROXIMAL SCREWS IN THE ANTERIOR PLATE HAVE MIGRATED AND THE STRUT GRAFT DISLODGED. THIS REPORT WILL CAPTURE THE SECOND OF THE TWO PROXIMAL SCREWS IMPLANTED IN THE POSTERIOR CERVICAL SPINE.

    Additional Manufacturer Narrative · 1

    IMPLANT STATUS OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH SOCIAL MEDIA THAT AN UNIDENTIFIED PATIENT EXPERIENCED AN UNKNOWN EVENT INVOLVING DEVICES MADE BY AN UNIDENTIFIED MANUFACTURER. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. THE PATIENT APPEARS TO HAVE BEEN IMPLANTED WITH A PLATE ON THE ANTERIOR SURFACE OF THE CERVICAL SPINE AND WITH SCREWS AND RODS ON THE POSTERIOR SURFACE OF THE CERVICAL SPINE. UPON PROFESSIONAL REVIEW OF THE POSTED X-RAY, IT HAS BEEN DETERMINED THAT THE DEVICES ARE INTACT. HOWEVER, IT APPEARS THAT THE PROXIMAL SCREWS IN THE POSTERIOR CERVICAL SPINE HAVE PULLED OUT, A KYPHOTIC DEFORMITY HAS OCCURRED, AND THE PROXIMAL SCREWS IN THE ANTERIOR PLATE HAVE MIGRATED AND THE STRUT GRAFT DISLODGED. THIS REPORT WILL CAPTURE THE SECOND OF THE TWO PROXIMAL SCREWS IMPLANTED IN THE POSTERIOR CERVICAL SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626018 POSTERIOR CERVICAL SCREW, MANUFACTURER UNKNOWN POSTERIOR CERVICAL SCREW SYSTEM NKG STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1