BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MONO/POLYAXIAL SCREWS

    MDR report key: 9565523 · Received January 8, 2020

    Report

    Report Number
    1526439-2020-00291
    Event Type
    Injury
    Date Received
    January 8, 2020
    Report Date
    December 12, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: INAMDAR D., ET AL (2006) POSTERIOR LUMBAR INTERBODY FUSION VERSUS INTERTRANSVERSE FUSION IN THE TREATMENT OF LUMBAR SPONDYLOLISTHESIS, JOURNAL OF ORTHOPAEDIC SURGERY, VOLUME 14(1): PAGES 21-26 (INDIA). THIS PROSPECTIVE STUDY AIMS TO COMPARE THE METHODS: POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AND POSTERIOR INTERTRANSVERSE FUSION (ITF) (ITF) IN THE TREATMENT OF LUMBAR SPONDYLOLISTHESIS WITH VARYING RESULTS. FROM JANUARY 1999 TO OCTOBER 2003, A TOTAL OF 22 PATIENTS WITH LUMBAR SPONDYLOLISTHESIS (GRADES 1¿4) AND SYMPTOMS SEVERE ENOUGH TO WARRANT SURGERY WERE INCLUDED IN THE STUDY. PATIENTS WERE RANDOMLY ASSIGNED TO ITF OR PLIF.11 PATIENTS RECEIVED ITF AND ANOTHER 11 PATIENTS RECEIVED PLIF. TWO PATIENTS WERE LOST TO FOLLOW-UP. THE MEAN AGE OF THE 10 PATIENTS WHO UNDERWENT PLIF AND COMPLETED FOLLOW-UP WAS 41.4 YEARS, AND THAT OF THE 10 PATIENTS WHO UNDERWENT ITF WAS 44.7 YEARS. THE SURGERY PERFORMED WAS DECOMPRESSION AND POSTERIOR INSTRUMENTATION (PEDICLE SCREWS; MOSS MIAMI, DEPUY, WARSAW [IN], US), WITH EITHER ITF OR PLIF. THE MEAN FOLLOW-UP PERIOD WAS ONE YEAR FOR PLIF CASES AND ONE YEAR 11 MONTHS FOR ITF CASES. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: THE CONDITION OF THE PLIF PATIENT WITH CAUDA EQUINA LESION PERSISTED. THE CONDITION OF THE PATIENT WITH CAUDA EQUINA LESION REMAINED UNRESOLVED AT A 6-MONTH FOLLOW-UP. POSTOPERATIVELY, COMPLETE RELIEF OF BACK PAIN WAS NOT ACHIEVED IN 10% OF PATIENTS WHO UNDERWENT PLIF AND 30% DID NOT HAVE COMPLETE RELIEF OF RADICULAR LEG PAIN. IN PATIENTS WHO UNDERWENT ITF, 20% DID NOT HAVE RELIEF OF RADICULAR LEG PAIN. THE MOTOR DEFICIT WAS NOT RELIEVED IN 30% OF THE PLIF PATIENTS. THERE WERE 2 CASES OF NONUNION IN THE ITF GROUP. IN THE ITF GROUP, 60% OF PATIENTS SHOWED EVIDENCE OF GRADE 3 UNION AND 40% GRADE-2 UNION (FIG. 2). TWO PATIENTS COMPLAINED OF UNRESOLVED BACK PAIN FOLLOWING SURGERY. TWO PATIENTS HAD PERSISTENT BACK AND LEG PAIN. TWO PATIENTS HAD AN UNRESOLVED NEUROLOGICAL DEFICIT. IN THE ITF GROUP, ONLY ONE PATIENT HAD PERSISTENT LEG PAIN AT A 3-YEAR FOLLOW-UP BUT NO OTHER COMPLICATIONS. PEDICLE SCREW BREAKAGE OCCURRED IN 1 PATIENT. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE POSTERIOR INSTRUMENTATION MOSS MIAMI, DEPUY, WARSAW [IN], US). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26191 UNKNOWN MONO/POLYAXIAL SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention