BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 11942707 · Received June 4, 2021

    Report

    Report Number
    1526439-2021-01117
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    December 11, 2010
    Report Date
    May 11, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    ODV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNKNOWN CAGE/SPACER/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTERS STATE: (B)(6). (B)(4). INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. 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

    YAO N., WANG C., WANG W., WANG L., (2011) FULL-ENDOSCOPIC TECHNIQUE FOR ANTERIOR CERVICAL DISCECTOMY AND INTERBODY FUSION: 5-YEAR FOLLOW-UP RESULTS OF 67 CASES, EUR SPINE J VOLUME 20, PAGES 899¿904 (CHINA). THIS STUDY AIMS TO REPORT THE FEASIBILITY OF ACDF USING AN ENDOSCOPIC TECHNIQUE, 76 PATIENTS WITH CERVICAL DISORDERS WERE TREATED BY THIS TECHNIQUE SINCE 2000. BETWEEN JANUARY 2000 AND JANUARY 2004, 76 PATIENTS WITH A MEAN AGE OF 50.3 YEARS (RANGE 35¿67 YEARS, 43 M/33 F), UNDERWENT ENDOSCOPIC ACDF FOR CERVICAL DISC HERNIATION. A TOTAL OF NINE PATIENTS WERE LOST TO FOLLOW UP. THUS, 67 PATIENTS WERE INCLUDED IN THIS STUDY. A PROPER CARBON FIBER REINFORCED POLYMER (CFRP) CAGE (DEPUY, USA) WAS SELECTED AND FILLED WITH AUTOGENIC ILIAC CREST BONE GRAFT PRIOR TO DEFINITIVE PLACEMENT. ALL PATIENTS WERE FOLLOWED UP OF A MINIMUM OF 5 YEARS (5¿8 YEARS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: ONE PATIENT REQUIRED REVISION BY MEANS OF OPEN ACDF BECAUSE OF ADJACENT SEGMENT DISC HERNIATION AFTER 6 YEARS POST-OPERATIVELY. 3 PATIENTS REPORTED POOR RESULTS. AT 6 MONTHS POSTOPERATIVELY, BONY FUSION WAS ACHIEVED IN 61 PATIENTS ONLY. WITH INCREASING TIME, AIH SLIGHTLY DECREASED WHEN COMPARED WITH THAT MEASURED IMMEDIATELY AFTER THE OPERATION. AT THE FINAL FOLLOW-UP, 42 PATIENTS WERE LORDOTIC, 19 PATIENTS WERE NEUTRAL, AND 6 PATIENTS (8.9%) HAD MEAN KYPHOTIC ALIGNMENT. SUBSIDENCE OF CRFP CAGE WAS OBSERVED IN FOUR PATIENTS. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE CFRP CAGE. THIS IMPACTED PRODUCT CAPTURES THE FOLLOWING ADVERSE EVENTS: SUBSIDENCE OF CRFP CAGE WAS OBSERVED IN FOUR PATIENTS. THIS REPORT IS FOR ONE (1) UNKNOWN CAGE/SPACER. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833329 UNKNOWN CAGE/SPACER INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR ODV MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1