BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CAGE/SPACERS: SYNCAGE

    MDR report key: 9087277 · Received September 19, 2019

    Report

    Report Number
    8030965-2019-68439
    Event Type
    Injury
    Date Received
    September 19, 2019
    Report Date
    August 22, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    OVD
    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 AN UNKNOWN SCREW/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KIM J., ET AL (2010), COMPARISON STUDY OF THE INSTRUMENTED CIRCUMFERENTIAL FUSION WITH INSTRUMENTED ANTERIOR LUMBAR INTERBODY FUSION AS A SURGICAL PROCEDURE FOR ADULT LOW-GRADE ISTHMIC SPONDYLOLISTHESIS ,WORLD NEUROSURGERY, VOLUME 73 (5),PAGES 565-571(KOREA, SOUTH). THIS (B)(6) STUDY AIMS TO EVALUATE THE RESULTS OBTAINED OF PATIENTS IN THE COMBINED GROUP COMPARED WITH THOSE OF THE PPF GROUP FOR THE TREATMENT OF LOWGRADE ISTHMIC SPONDYLOLISTHESIS, WITH A GOAL TOWARD HELPING IN THE SELECTION OF TREATMENT OPTIONS. BETWEEN JANUARY 2003 AND NOVEMBER 2004, 43 PATIENTS (13 MALE AND 30 FEMALE) WITH AN AVERAGE AGE (YEARS) OF 50.5 WHO UNDERWENT ALIF WITH PPF (THE PPF GROUP) THEN BETWEEN FEBRUARY 2003 AND OCTOBER 2006, 32 CONSECUTIVE PATIENTS (7 MALE AND 25 FEMALE) WITH AN AVERAGE AGE (YEARS) 51 WHO UNDERWENT CIRCUMFERENTIAL FUSION WITH INSTRUMENTATION (THE COMBINED GROUP) WERE INCLUDED IN THE STUDY. THE PPF GROUP WAS TREATED WITH LORDOTIC CAGE( SYNCAGE; SYNTHES, OBERDORF, SWITZERLAND) AND OTHER COMPETITORS DEVICE WHILE THE COMBINED GROUP WAS TREATED WITH A COMPETITOR'S DEVICE. MEAN FOLLOW-UP DURATION (MONTHS) FOR PPF GROUP IS 41.1 AND FOR COMBINED GROUP IS 32.9. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PFF GROUP: THE MEAN DH CHANGED FROM 8.0 TO 15.9 MM (P.001) AFTER SURGERY IN THE PPF. THE MEAN PREOPERATIVE VALUES FOR SL, WL, AND THE DEGREE OF LISTHESIS (%) IN THE PPF GROUP WERE 13.9, 50.6, AND 21.9, RESPECTIVELY; THEY CHANGED TO 20.8 (P .001), 56.3 (P .001), AND 11.3 (P .001) AT FOLLOW-UP. RADIOLOGIC EVIDENCE SHOWED UNSUCCESSFUL ARTHRODESIS IN 1 PATIENT IN THE PPF GROUP. THE MEAN VAS SCORES FOR BACK AND LEG PAIN SIGNIFICANTLY DECREASED FROM 7.6 TO 2.1 AND 7.5 TO 2.0 IN THE PPF GROUP. 1 CASE OF POSTOPERATIVE PNEUMONIA AND ONE CASE OF A URINARY TRACT INFECTION IN THE PPF GROUP, WHICH WERE CONTROLLED WITH ANTIBIOTICS. COMPLICATIONS RELATED TO THE ALIF PROCEDURE INCLUDED ONE VENOUS INJURY IN THE PPF GROUP. THIS REPORT IS FOR AN UNKNOWN SYNTHES LORDOTIC CAGE SYNCAGE. THIS IS REPORT 1 OF 1 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882169 UNK - CAGE/SPACERS: SYNCAGE INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR OVD OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention