BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

    MDR report key: 4730394 · Received April 27, 2015

    Report

    Report Number
    2520274-2015-12946
    Event Type
    Injury
    Date Received
    April 27, 2015
    Report Date
    March 30, 2015
    Manufacturer
    SYNTHES(USA)
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MAJD, M. (1999) ANTERIOR CERVICAL RECONSTRUCTION USING TITANIUM MESH CAGES WITH ANTERIOR PLATING, SPINE 24: 1604-10. (B)(4). THIS REPORT IS FOR AN UNKNOWN CSLP PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: MAJD, M. (1999) ANTERIOR CERVICAL RECONSTRUCTION USING TITANIUM MESH CAGES WITH ANTERIOR PLATING, SPINE 24: 1604-10. THIS WAS A PRELIMINARY OUTCOME ASSESSMENT STUDY OF TITANIUM CAGE IMPLANTS WITH ANTERIOR CERVICAL PLATING IN ANTERIOR CERVICAL RECONSTRUCTION. THE OBJECTIVE OF THE STUDY WAS TO EVALUATE THE EFFICACY AND SAFETY OF USING TITANIUM CAGE IMPLANTS AND ANTERIOR PLATING IN CERVICAL RECONSTRUCTION. THIRTY-FOUR PATIENTS WERE TREATED BY CHANNEL CORPECTOMY FOLLOWED BY PLACEMENT OF A TITANIUM CAGE PACKED WITH AUTOGENOUS BONE GRAFT FROM VENTRAL BODIES TO RECONSTRUCT THE ANTERIOR COLUMN. AN ANTERIOR CERVICAL PLATE WAS ADDED IN 30 OF 34 CASES THAT INVOLVED DECOMPRESSION OF TWO OR MORE LEVELS. SYNTHES IMPLANTS ((B)(4)) WERE USED FOR THE CERVICAL FIXATION. THE AVERAGE FOLLOW-UP PERIOD WAS 32 MONTHS AND INCLUDED EXAMINATION AND RADIOGRAPHY. SIX MONTHS AFTER SURGERY, THERE WAS RADIOGRAPHIC EVIDENCE OF FUSION IN 97% OF THE PATIENTS. THE CLINICAL OUTCOME WAS EXCELLENT OR GOOD IN 80% OF THE PATIENTS. EIGHTY-EIGHT PERCENT OF THE PATIENTS DID NOT EXPERIENCE ANY COMPLICATIONS. FOR COMPLICATIONS REPORTED IN UNIDENTIFIED PATIENTS WITH RESULTED IN NON-UNION (1), KYPHOSIS (1) AND RADICULOPATHY (1). THERE IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR: UNKNOWN CLSP PLATE/ UNKNOWN QUANTITY/UNKNOWN LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275438 APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES(USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention