BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MEDTRONIC HARDWARE

    MDR report key: 4183022 · Received October 17, 2014

    Report

    Report Number
    1030489-2014-04071
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    October 22, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: MEDICAL ASSESSMENT SUBMITTED ARE FOUR X-RAYS. AN AP AND LATERAL IMMEDIATELY POSTOP AND AN AP AND LATERAL DONE LATER, AFTER THE PATIENT REPORTED INTENSE PAIN AND INABILITY TO SWALLOW SOLIDS. THIS INITIAL SET OF FILMS SHOW A CAGE PLACED AT C5/6 WITH A SOLID ACDF AT THE LEVEL BELOW. NO METAL REMAINS IN PLACE ALTHOUGH THE AP SHOWS SIGNS OF OLD SCREW HOLES. IT IS PRESUMED THIS WAS REMOVED AT THE TIME OF THE CAGE PLACEMENT. OF NOT THE INFERIOR SCREW PLACED INTO C6 IS PLACED FAR TOO FLAT, SUGGESTING IT MAY HAVE BEEN DEFLECTED BY THE SUPERIOR ENDPLATE OF C6. IT IS SO FLAT THAT IT IS OUT OF DESIGN SPEC FOR THE LOCKING MECHANISM AND WOULD NOT HAVE BEEN HELD SECURELY. THESE TWO FINDINGS: 1) INADEQUATE BONE PURCHASE OF THE SCREW DEFLECTED PARTIALLY INTO THE DISC SPACE AND 2) THE EXTREME ANGULATION OF THE SCREW IN RELATION TO THE CAGE LOCKING MECHANISM, ARE MOST PROBABLY THE REASON THE SCREW ULTIMATELY BACKED OUT. THE SECOND SET OF VIEWS SHOW SIMILAR AP AND LATERAL VIEWS AFTER THE INFERIOR SCREW BACKED OUT AND PRESUMABLY ERODED INTO THE ESOPHAGUS AND WAS PASSED OUT OF THE BODY. THE FUSION APPEARS SOLID, ALTHOUGH THE ISSUES OF ESOPHAGEAL EROSION AND THE POSSIBLE HEALTH RISKS THAT THIS COULD HAVE CREATED DEFINITELY MAKE THIS REPORTABLE.

    Additional Manufacturer Narrative · 1

    THE COMMON DEVICE NAME SHOULD BE UNKNOWN. (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION AT C4-C5. THEREAFTER, THE PATIENT EXPERIENCED FIERCE PAIN IN THROAT AND BECAME UNABLE TO SWALLOW SOLIDS. APPROXIMATELY ONE MONTH LATER, AN EXAMINATION REVEALED A SCREW COMING-OFF OF A CAGE. IT WAS REPORTED THAT THE CAUDAL SCREW WAS NOT CONFIRMED ON IMAGING. LATER THE PATIENT¿S CONDITION WAS WELL. THE PHYSICIAN SAID THAT THE "DROPPED SCREW MIGHT HAVE ENTERED THE ESOPHAGUS. THE SURGEON COMMENTED THAT "THE STRENGTH OF LOCKING WIRE MECHANISM SEEMED TO BE NOT STRONG ENOUGH. SO, WHEN IT WAS BROKEN, THE SCREW MIGHT HAVE COME OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662227 UNKNOWN MEDTRONIC HARDWARE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL KWQ MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Other CAGE