BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIANCE,FIXATION, SPINAL INTERVERTEBRAL BODY

    MDR report key: 5410435 · Received February 4, 2016

    Report

    Report Number
    2520274-2016-10735
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    April 18, 2012
    Report Date
    January 25, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN CERVICAL SPINE LOCKING PLATE (CSLP)/UNKNOWN QUANTITY/UNKNOWN LOT/ (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: SONG, K.J., LEE, K.B. AND SONG, J.H.(2012) EFFICACY OF MULTILEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION VERSUS CORPECTOMY AND FUSION FOR MULTILEVEL CERVICAL SPONDYLOTIC MYELOPATHY: A MINIMUM 5-YEAR FOLLOW-UP STUDY. EUR SPINE J (2012) 21:1551-1557. SOUTH KOREA. PURPOSE OF STUDY: THE AUTHORS EVALUATED RADIOLOGIC AND CLINICAL OUTCOMES TO COMPARE THE EFFICACY OF ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AND ANTERIOR CORPECTOMY AND FUSION (ACCF) FOR MULTILEVEL CERVICAL SPONDYLOTIC MYELOPATHY (CSM). PATIENT DEMOGRAPHIC: A TOTAL OF 40 PATIENTS WHO UNDERWENT ACDF OR ACCF FOR MULTILEVEL CSM WERE DIVIDED INTO TWO GROUPS. GROUP A (N = 25) UNDERWENT ACDF AND GROUP B (N = 15) ACCF. GROUP A (N = 25) INCLUDED PATIENTS WHO UNDERWENT MULTILEVEL ACDF (FIG. 1A-I), [MEAN AGE 50.3 +/- 7.5 YEARS (MIN 42, MAX 73); 19 MALES AND 6 FEMALES. GROUP B (N = 15) WAS COMPRISED OF PATIENTS WHO UNDERWENT MULTILEVEL ACCF (FIG. 2A-I), [MEAN AGE 54.1 +/- 9.8 YEARS (MIN 45, MAX 70) 11 MALES AND 4 FEMALES. TYPE OF SURGERY: ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) OR ANTERIOR CORPECTOMY AND FUSION (ACCF) FOR MULTILEVEL CERVICAL SPONDYLOTIC MYELOPATHY (CSM). IMPLANTS USED: CERVICAL SPINE LOCKING PLATE (CSLP), AO SYNTHES AND UNKNOWN SCREW. THIS IS FOR GROUP A COMPLICATIONS / REPORTABLE MALFUNCTION: PLATE BENDING (2). THIS IS REPORT 3 OF 4 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN CERVICAL SPINE LOCKING PLATE(CSLP), AO SYNTHES. A COPY OF THE LITERATURE ARTICLE (OR ABSTRACT) IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68744 APPLIANCE,FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention