BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SYNEX(TM) II CENTRAL BODY 58MM-84MM LENGTH

    MDR report key: 3090385 · Received May 2, 2013

    Report

    Report Number
    2520274-2013-02292
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQP
    PMA / PMN Number
    K061891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). DEVICE PART AND LOT NUMBERS WERE OBTAINED AFTER DEVICE EXPLANTATION ON 11/6/2013. DEVICE MANUFACTURER INFORMATION WAS IDENTIFIED AND ADDED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RECEIVED FOR EVALUATION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.AS OF THIS REPORT THE DEVICE HAS NOT BEEN EXPLANTED AND HAS NOT BEEN RETURNED TO SYNTHES FOR EVALUATION. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY UNDERWENT REVISION SURGERY TO REMOVE THE SYNEX II CENTRAL BODY CAGE AND TWO SYNEX II ENDPLATES DUE TO INFECTION, LOOSING, BREAKAGE AND IMPLANT MIGRATION ON (B)(6) 2013. THE PATIENT HAD UNDERGONE SURGERY TO REMOVE A COMPETITOR SCREWS AND RODS APPROXIMATELY TWO WEEKS PRIOR TO THIS DATE. IT WAS NOTED DURING THE SURGERY THAT THE SUPERIOR ENDPLATE WHICH WAS STILL ATTACHED TO THE CAGE BUT THE INFERIOR ENDPLATE WAS NOT ATTACHED AND A PIECE OF IT HAD BROKEN OFF INTO THE PATIENT. THE PATIENT REPORTEDLY LOST A LARGE AMOUNT OF BLOOD DURING SURGERY AND THE IMPLANTS WERE LODGED DEEP IN THE SPINE. SURGICAL TIME WAS REPORTED AS APPROXIMATELY THREE HOURS. THE IMPLANTS AND THE BROKEN ENDPLATE PIECE WERE SUCCESSFULLY REMOVED. THE SURGEON STATED THAT THE PATIENT HAD OSTEOMYELITIS AND A LIFE-THREATENING INFECTION, SO AT THIS TIME, THERE WAS NO PLAN TO RE-INSTRUMENT THE PATIENT UNTIL THE INFECTION HAD CLEARED UP AND THE BEST TREATMENT OPTION FOR THE PATIENT COULD BE DETERMINED. THIS REPORT IS FOR ONE, TI SYNEX(TM) II CENTRAL BODY 58MM-84MM LENGTH. THIS REPORT IS 1 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH SYNEX II AND COMPETITOR PEDICLE SCREW HARDWARE ON (B)(6) 2008. PROCEDURE WAS POSTERIOR LUMBAR FUSION SURGERY (B)(6) 2008, INVOLVING CORPECTOMY AT L4-L5, COMPETITOR SCREWS AND RODS WERE IMPLANTED AT L2, S1. RECENT EXAM INDICATES POSSIBLE INFECTION AT THE SURGICAL SITE, BUT SURGEON NOTED A COLOSTOMY WOULD NEED TO BE PERFORMED PRIOR TO SPINAL SURGERY REVISION. COLOSTOMY HAS NOW BEEN PERFORMED. EXPLANT SURGEON HAS SCHEDULED A FOLLOW UP APPOINTMENT ON (B)(6) 2013 REGARDING TREATMENT PLANS AND POSSIBLE EXPLANT SURGERY. PATIENT HAS HAD (B)(6) AND AND LYMPHOMA SINCE 2005. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191210 TI SYNEX(TM) II CENTRAL BODY 58MM-84MM LENGTH MQP SYNTHES GMBH 1692245

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention MEDTRONIC SCREWS AND RODS