BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: VENTROFIX

    MDR report key: 8798816 · Received July 17, 2019

    Report

    Report Number
    8030965-2019-66301
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    April 30, 2004
    Report Date
    June 21, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: VENTROFIX/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. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LINHARDT O., KRÜGER A., KRÖDEL A., (2004), DIFFERENCES BETWEEN ANTEROPOSTERIOR AND POSTERIOR SPONDYLODESIS IN CLINICAL SCORES, TRAUMA SURGEON 2004, VOLUME 107, PAGES 593-600 (GERMANY) DOI 10.1007/S00113-004-0775-1. THIS STUDY AIMS TO COMPARE PROSPECTIVE RESULTS OF CLINICAL SCORES OF PATIENTS TREATED WITH ANTEROPOSTERIOR OR ANTERIOR SPONDYLODESIS. . FROM FEBRUARY 1997 TO DECEMBER 1998, A TOTAL OF 22 PATIENTS WITH SPONDYLITIS WERE RANDOMLY OPERATED ON WITH VENTRODORSAL OR VENTRAL SPONDYLODESIS. THESE PATIENTS WERE DIVIDED INTO TWO GROUPS. A TOTAL OF 12 PATIENTS (8 MALE AND 4 FEMALE)AND AT THE TIME OF SURGERY, THE AGE WAS BETWEEN 20 AND 75 YEARS, WITH A MEAN AGE OF 57.2 YEARS WERE IN VENTRODORSAL SPONDYLODESIS (GROUP 1,) TREATED WITH VENTRODORSAL SPONDYLODESIS. DORSAL INSTRUMENTATION WAS PERFORMED WITH UNIVERSAL SPINE SYSTEM® BY HOOK FIXATION ABOVE T8 OR BY TRANSPEDICULAR SCREWING CAUDAL TO T8. A TOTAL OF 10 PATIENTS (8 MALE AND 2 FEMALE) WITH A MEDIAN AGE AT THE TIME OF SURGERY WERE IN VENTRAL SPONDYLODESIS (GROUP 2) TREATED WITH VENTRAL SPONDYLODESIS VENTROFIX® INSTRUMENTATION, IMPLANTED THROUGH THE SAME VENTRAL APPROACH FOR STABILIZATION. PATIENTS FROM BOTH GROUPS WERE INTERVIEWED, PREOPERATIVELY, 2 WEEKS POSTOPERATIVELY, 3 MONTHS POSTOPERATIVELY, 6 MONTHS POSTOPERATIVELY AND 12 MONTHS POSTOPERATIVELY USING THE SF-36, THE "OSWESTRY LOW-BACK PAIN DISABILITY QUESTIONNAIRE" AND THE VISUAL PAIN SCALES. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP 1: VENTRODORSAL SPONDYLODESIS. INTRA- AND POSTOPERATIVE COMPLICATIONS. 3 PATIENTS HAD REVERSIBLE PARESTHESIA LAT. FOOTBACK DUE TO PERONEAL LESION AFTER FIBULA REMOVAL. 1 PATIENT HAD REACTIVATION OF SPONDYLITIS (1 YEAR POSTOPERATIVELY). 2 WEEKS POST-OPERATIVELY AN INCREASED OF SCORE WAS OBSERVED IN THE VENTRODORSAL SPONDYLODESIS GROUP ACCORDING TO PATIENT DISABILITY BECAUSE OF PAIN (GROUP 1). 1 PATIENT DIED (3 MONTHS POSTOPERATIVELY DUE TO SEPSIS). GROUP 2: VENTRAL SPONDYLODESIS. INTRA- AND POSTOPERATIVE COMPLICATIONS. 3 PATIENTS HAD REVERSIBLE PARESTHESIA LAT. FOOTBACK DUE TO PERONEAL LESION AFTER FIBULA REMOVAL. 1 CASE OF URINARY INFECTON. 1 CASE OF PARALYTIC ILEUS. 1 CASE OF TRANSITIONAL SYNDROME. 1 CASE OF IMPLANT FRACTURE. 1 DEATH (3 MONTHS POSTOPERATIVELY DUE TO SUICIDE). THIS REPORT IS FOR AN UNKNOWN SYNTHES VENTROFIX. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592878 UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: VENTROFIX SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention