BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CAGE/PLATE: SYNFIX-LR

    MDR report key: 11837686 · Received May 17, 2021

    Report

    Report Number
    8030965-2021-03983
    Event Type
    Injury
    Date Received
    May 17, 2021
    Report Date
    April 20, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNK - CAGE/PLATE: SYNFIX-LR/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: RAO PJ, ET AL (2017), SUBSIDENCE FOLLOWING ANTERIOR LUMBAR INTERBODY FUSION (ALIF): A PROSPECTIVE STUDY, J SPINE SURG, VOLUME 3 (2), PAGE 168-175 (AUSTRALIA). THIS STUDY PROSPECTIVELY EVALUATED THE RATE OF SUBSIDENCE IN ADULT PATIENTS UNDERGOING ANTERIOR LUMBAR INTERBODY FUSION (ALIF). FROM 2011 TO 2013, 147 PATIENTS WHO UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION (ALIF) WERE INCLUDED IN THE STUDY. 65 OF THE PATIENTS WERE FEMALE. THE MEAN AGE OF THE STUDY GROUP WAS 57.3±13.6 YEARS. PATIENTS RECEIVED STAND-ALONE PEEK INTEGRAL CAGE DEVICES. IN PARTICULAR, THE VAST MAJORITY (89.1 PERCENT) RECEIVED THE UNKNOWN SYNFIX-LR PEEK INTEGRAL CAGE DEVICE. A COMPETITOR¿S BONE GRAFT SUBSTITUTE WAS USED FOR 136 PATIENTS. FOR THE REMAINING 11 PATIENTS, A COMPETITOR¿S RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN 2 (RHBMP2) WAS USED. DISC HEIGHTS WERE MEASURED ON CT SCANS TAKEN PRE-OPERATIVELY, IMMEDIATELY POST-OPERATIVELY, ON ERECT X-RAYS AT 6 WEEKS POSTOPERATIVELY, CT SCANS AT 6-MONTH-POSTOPERATIVELY WHEN EVALUATING FUSION AND USING THE LATEST AVAILABLE CT SCAN PERFORMED AS CLINICALLY INDICATED. COMPLICATIONS WERE REPORTED: 15 PATIENTS HAD SUBSIDENCE OF MEAN 4.7 MM (RANGE, 2.4¿7.8). THESE WERE ALL DELAYED CAGE SUBSIDENCE (DCS). THESE PATIENTS HAD TYPE 1 (CAUDAL ENDPLATE) SUBSIDENCE; 3 WITH ANTERIOR, 2 WITH POSTERIOR AND 10 WITH BOTH ANTERIOR AND POSTERIOR SUBSIDENCE. 11 PATIENTS DID NOT DEMONSTRATE FUSION AT THE LATEST RADIOLOGICAL FOLLOW-UP. THIS REPORT IS FOR THE UNKNOWN SYNFIX-LR PEEK INTEGRAL CAGE DEVICE. THIS REPORT IS FOR (1) UNK - CAGE/PLATE: SYNFIX-LR. THIS REPORT IS 2 OF 2 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732414 UNK - CAGE/PLATE: SYNFIX-LR INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR OVD SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention