BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CAGE/SPACERS: SYNCAGE

    MDR report key: 10809306 · Received November 9, 2020

    Report

    Report Number
    8030965-2020-08753
    Event Type
    Injury
    Date Received
    November 9, 2020
    Report Date
    October 13, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS. ALL KNOWN INFORMATION IS PROVIDED IN THE LITERATURE ARTICLE. THIS REPORT IS FOR AN UNKNOWN SYNCAGE /UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANT IS AN UNKNOWN DATE BETWEEN FEBRUARY 2001 AND DECEMBER 2004. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. (B)(4). 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) WHICH LUMBAR INTERBODY FUSION TECHNIQUE IS BETTER IN TERMS OF LEVEL FOR THE TREATMENT OF UNSTABLE ISTHMIC SPONDYLOLISTHESIS?, JOURNAL OF NEUROSURGERY SPINE, VOLUME 12, PAGES 171¿177 ((B)(6))DOI: 10.3171/2009.9.SPINE09272. THIS STUDY AIMS TO EVALUATE RETROSPECTIVELY THE RESULTS OBTAINED IN PATIENTS UNDERGOING 2 COMMON LIF TECHNIQUES, INSTRUMENTED MINI-TLIF COMPARED WITH INSTRUMENTED MINI-ALIF FOR THE TREATMENT OF LOW-GRADE ISTHMIC SPONDYLOLISTHESIS, WITH A GOAL OF HELPING IN THE SELECTION OF TREATMENT OPTIONS. BETWEEN FEBRUARY 2001 AND DECEMBER 2004, 86 PATIENTS MEAN AGE WAS 54.3 YEARS UNDERWENT INSTRUMENTED MINI-ALIF (GROUP I: L4¿5, 42 PATIENTS; L5¿S1, 44 PATIENTS) USING A LARGE, WEDGE-SHAPED, LORDOTIC CAGE (SYNCAGE, SYNTHES) PEDICLE SCREW FIXATIONS WERE PERFORMED USING THE SEXTANT SYSTEM (MEDTRONIC SOFAMOR DANEK). BETWEEN NOVEMBER 2003 AND DECEMBER 2004, 42 PATIENTS MEAN AGE WAS 51.2 YEARS WERE TREATED WITH INSTRUMENTED MINI-TLIF (GROUP II: L4¿5, 22 PATIENTS; L5¿S1, 20 PATIENTS) USING A CAGE (POLYETHERETHERKETONE OR FIDJI CAGE) FILLED WITH GRAFT MATERIAL AND PEDICLE SCREWS . MINIMUM FOLLOW-UP PERIOD WAS 2 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED: IN GROUP I, THERE WERE 3 CASES OF SYMPATHETIC CHANGES, WHICH WERE RESTORED TO A NORMAL STATE 2 4 MONTHS POST-SURGERY. THIS REPORT IS FOR AN UNKNOWN SYNTHES SYNCAGE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278082 UNK - CAGE/SPACERS: SYNCAGE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention