BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 5020436 · Received August 21, 2015

    Report

    Report Number
    1030489-2015-02027
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    July 23, 2015
    Report Date
    August 28, 2015
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS:VISUAL REVIEW CONFIRMS BONE SCREW RETAINED UPON RECEIPT FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 876-713, 876-853, 510K # K970806 WAS CLEARED IN THE UNITED STATES. THE DEVICE HAS BEEN RETURNED. THE EVALUATION HAS NOT YET STARTED HENCE, NO CONCLUSION CAN BE DRAWN AS OF NOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGERY AT C4-5 LEVELS. A WEEK AFTER THE SURGERY, LOOSENING OF A LOCKING SCREW AND SCREW WAS FOUND BY RADIOGRAPHY. THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2015. POSTERIOR FUSION IS ALSO PLANNED FOR THE REVISION SURGERY. DOCTOR'S COMMENT: SCREW WAS PLACED PROPERLY UNDER A WASHER AND LOCKING SCREW WAS FULLY TIGHTENED SO THE REASON OF LOOSENING IS UNKNOWN. ON (B)(6) 2015, THE PATIENT UNDERWENT REVISION SURGERY. AUTOGRAFT IMPLANT, WHICH WAS IMPLANTED IN FIRST SURGERY, WAS REMOVED FROM THE ANTERIOR APPROACH. POSTERIOR FUSION WAS DONE AT C2-C6 LEVELS. TWO SCREWS AT CRANIAL SIDE BACKED OUT. PATIENT'S BONE WAS BAD AND A SCREW WAS REMOVED SO EFFORTLESSLY. SCREW AT DORSAL SIDE DIDN'T BACK OUT BUT THE SCREW WAS VERY LOOSE TO THE DEGREE THAT IT COULD BE PULLED OUT WITH THE PLATE. AT THE TIME OF FIXATION LOCKING MAY NOT HAVE BEEN PROPERLY DONE. THE SURGEON COMMENTED THAT LOCKING WAS HARD TO DO. SALES REP COMMENTED THAT MICRO WAS NOT USED FOR THE PATIENT AND CHECK MIGHT HAVE BEEN IMPROPER DUE TO PATIENT'S OLD AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556295 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5161156

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention