BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MONO/POLYAXIAL SCREWS

    MDR report key: 12455261 · Received September 10, 2021

    Report

    Report Number
    1526439-2021-01946
    Event Type
    Injury
    Date Received
    September 10, 2021
    Report Date
    August 13, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN MONO/ POLYAXIAL SCREW/ UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN DECEMBER 2012 TO JUNE 2014. 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. 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: ZENG Z.L., (2015) ANALYSIS OF RISK FACTORS FOR ADJACENT SUPERIOR VERTEBRAL PEDICLE-INDUCED FACET JOINT VIOLATION DURING THE MINIMALLY INVASIVE SURGERY TRANSFORAMINAL LUMBAR INTERBODY FUSION: A RETROSPECTIVE STUDY, EUR J MED RES VOLUME 20, PAGES 1-7, (CHINA). THIS RETROSPECTIVE STUDY AIMS TO REVIEW THE CLINICAL DATA OF 69 PATIENTS WHO UNDERWENT MIS-TLIF, AND ASSESSED RELEVANT RISK FACTORS OF FACET JOINT VIOLATION CAUSED BY ADJACENT SUPERIOR VERTEBRAL PEDICLE SCREW, INCLUDING GENDER, AGE, BMI, THE LOCATION OF ADJACENT UPPER VERTEBRAL, FUSION SEGMENT NUMBERS, SCREW IMPLANT LOCATION AND OTHERS. FROM DECEMBER 2012 TO JUNE 2014, 95 CONSECUTIVE PATIENTS WITH A LUMBAR DEGENERATIVE DISEASE (MALE, 35; FEMALE, 34; AVERAGE AGE: 54.8 ± 4.8 YEARS) UNDERWENT MINIMALLY INVASIVE SURGERY TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF) WERE REVIEWED IN THIS STUDY. OF THE 95 PATIENTS, 73 PATIENTS MET THE INCLUSION CRITERIA. THEN, 4 PATIENTS WERE EXCLUDED. FINALLY, 69 PATIENTS (WERE INCLUDED IN THE STUDY WITH COMPLETE MEDICAL RECORDS AND FOLLOW-UP DATA. DURING THE SURGERY, FASCIAE. AFTER INSERTING THE DILATORS STEP BY STEP, THE PIPELINE WORKING CHANNEL (JOHNSON & JOHNSON COMPANY, NY, USA, WAS PLACED INTO AND FIXED BY DILATORS, OR DIRECTLY USING THE SPOTLIGHT WORKING CHANNEL (JOHNSON & JOHNSON COMPANY, NY, USA). PLACEMENT OF PERCUTANEOUS PEDICLE SCREWS WAS PERFORMED USING VIPER2 SYSTEM (JOHNSON & JOHNSON COMPANY, NY, USA) AND THE PERCUTANEOUS ROD WAS ALSO PLACED USING THE INSTRUMENTS AND PRE-LOCKED. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PRESENCE OF OBVIOUS PEDICLE SCREW POSITION DEVIATION OR EVEN NEEDING A SECOND REVISION SURGERY BECAUSE OF NON-STANDARD SURGICAL MANIPULATION. THE POSTOPERATIVE CT SCANS SHOWED THE LOCATION RELATIONSHIP BETWEEN VERTEBRAL PEDICLE SCREW (TOTAL NUMBER: 138) AND FACET JOINT: NO POINT, (N = 103); ONE POINT, (N = 22); TWO POINTS (N = 13). WHERE NO POINT INDICATED THE VERTEBRAL PEDICLE SCREW CLEARLY AVOIDS THE FACET JOINT, ONE POINT INDICATED THE VERTEBRAL PEDICLE SCREW HEAD IS EITHER IN CONTACT WITH OR SUSPECTED TO HAS INVADED THE FACET JOINT, AND TWO POINTS INDICATE THE SCREW HAS CLEARLY INVADED THE FACET JOINT. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE VIPER 2 SYSTEM. THIS REPORT IS FOR ONE (1) UNKNOWN MONO/POLYAXIAL SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351432 UNKNOWN MONO/POLYAXIAL SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention