BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS

    MDR report key: 9111432 · Received September 24, 2019

    Report

    Report Number
    8030965-2019-68625
    Event Type
    Injury
    Date Received
    September 24, 2019
    Report Date
    August 29, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN SPINE SCREWS / UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW / INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SONG, K.J., CHOI, B.W. AND KIM, J.K. (2014), ADJACENT SEGMENT PATHOLOGY FOLLOWING ANTERIOR DECOMPRESSION AND FUSION USING CAGE AND PLATE FOR THE TREATMENT OF DEGENERATIVE CERVICAL SPINAL DISEASES, ASIAN SPINE JOURNAL, VOL. 8(6), PAGES, 720-728 (SOUTH KOREA). THE PURPOSE OF THIS STUDY IS TO ANALYZE THE INCIDENCE AND PREVALENCE OF CLINICAL ADJACENT SEGMENT PATHOLOGY (CASP) FOLLOWING ANTERIOR DECOMPRESSION AND FUSION WITH CAGE AND PLATE AUGMENTATION FOR DEGENERATIVE CERVICAL DISEASES. FROM JANUARY 2002 TO MAY 2010, A TOTAL OF 231 PATIENTS (137 MALES AND 94 FEMALES) WITH AN AVERAGE AGE OF 54.37 WERE TREATED WITH A CERVICAL SPINE LOCKING PLATE (AO NORTH AMERICA, PAOLI, PA, USA). THE CASES WERE DIVIDED INTO TWO GROUPS OF CASP GROUP, FOR THOSE WITH DEVELOPMENT OF CASP, AND THE DISEASE-FREE (DF) GROUP. THE FOLLOW-UP DURATION WAS 63.85 MONTHS (RANGE, 36.0¿123.6 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR-OLD FEMALE COMPLAINED OF A RECURRENT RIGHT RADIATING SYMPTOM AND SHE ALSO COMPLAINED OF CHRONIC DYSPHAGIA AFTER THE FIRST OPERATION. THE MRI SHOWED ADJACENT C6-C7 LEVEL ROOT DECOMPRESSION. 15 PATIENTS HAD CASP AFTER THE FIRST SURGERY. AT THE 8-YEAR FOLLOW-UP, THE AVERAGE ANNUAL INCIDENCE OF CASP WAS 1.1%. DF SURVIVAL BASED ON THE KAPLAN-MEIER SURVIVAL ANALYSIS WAS 93.6% AT 5 YEARS AND 90.2% AT 8 YEARS. AN INCREASE IN LORDOSIS WAS OBSERVED IN BOTH GROUPS COMPARED TO PREOPERATIVE SAGITTAL ALIGNMENT. 119 PATIENTS HAD RADIOLOGICAL DEGENERATIVE CHANGES, OF WHICH 15 DEVELOPED ADJACENT SEGMENT DISEASE (ASDZ). THIS IS REPORT 4 OF 4 FOR (B)(4). THIS REPORT IS FOR CERVICAL SPINE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903980 UNK - SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention