BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MONO/POLYAXIAL SCREWS

    MDR report key: 9820746 · Received March 11, 2020

    Report

    Report Number
    1526439-2020-00697
    Event Type
    Injury
    Date Received
    March 11, 2020
    Date of Event
    October 17, 2019
    Report Date
    February 14, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN EXPEDIUM SPINE SYSTEM SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KREINEST M, ET AL. (2019), COMPARISON OF PEDICLE SCREW MISPLACEMENT FOLLOWING OPEN VS. PERCUTANEOUS DORSAL INSTRUMENTATION AFTER TRAUMATIC SPINAL FRACTURE, EUROPEAN JOURNAL OF TRAUMA AND EMERGENCY SURGERY, HTTPS://DOI.ORG/10.1007/S00068-019-01245-8 (GERMANY). THE AIM OF THE PRESENT STUDY WAS TO COMPARE OPEN DORSAL INSTRUMENTATION WITH PERCUTANEOUS DORSAL INSTRUMENTATION IN TERMS OF PEDICLE SCREW MISPLACEMENT AND TO ASSESS POSSIBLE RISK FACTORS ASSOCIATED WITH PEDICLE SCREW MISPLACEMENT. BETWEEN JANUARY 2007 TO MARCH 2014, 491 PATIENTS (WITH 681 VERTEBRAL BODY FRACTURES) WHO SUFFERED A TRAUMATIC SPINAL FRACTURE THAT WERE TREATED WITH DORSAL STABILIZATION WERE INCLUDED IN THE STUDY. FROM JANUARY 2007 TO JUNE 2009, AN OPEN SURGICAL PROCEDURE WAS USED, AND FROM JUNE 2009 TO MARCH 2014 THE PERCUTANEOUS PROCEDURE WAS USED FOR ALL TYPES OF FRACTURES. THE OPEN SURGERY PROCEDURE WAS PERFORMED IN 169 PATIENTS (45 FEMALES,124 MALES) WITH 224 VERTEBRAL BODY FRACTURES USING EXPEDIUM SPINE SYSTEM. MEANWHILE, THE PERCUTANEOUS SURGERY PROCEDURE WAS PERFORMED IN 322 PATIENTS (90 FEMALES, 232 MALES) WITH 457 VERTEBRAL BODY FRACTURES USING THE VIPER 2 MIS SPINE SYSTEM. A TOTAL OF 733 PEDICLE SCREWS WERE PLACED USING THE OPEN SURGERY PROCEDURE, AND 1884 PEDICLE SCREWS WERE PLACED PERCUTANEOUSLY. THUS, A TOTAL OF 2617 PEDICLE SCREWS WERE ANALYZED. COMPLICATIONS WERE REPORTED AS FOLLOWS: (OPEN SURGERY): 84 MISPLACED SCREWS WITH BREACHING OF NO MORE THAN 2 MM IN LATERAL DIRECTION. 47 MISPLACED SCREWS WITH BREACHING OF NO MORE THAN 2 MM IN MEDIAL DIRECTION. 21 MISPLACED SCREWS WITH BREACHING OF 2-4 MM IN LATERAL DIRECTION. 4 MISPLACED SCREWS WITH BREACHING OF 2-4 MM IN MEDIAL DIRECTION. 3 MISPLACED SCREWS WITH BREACHING OF MORE THAN 4 MM IN LATERAL DIRECTION. 1 MISPLACED SCREW WITH BREACHING OF NO MORE THAN 4 MM IN MEDIAL DIRECTION. (PERCUTANEOUS SURGERY): 121 MISPLACED SCREWS WITH BREACHING OF NO MORE THAN 2 MM IN LATERAL DIRECTION. 77 MISPLACED SCREWS WITH BREACHING OF NO MORE THAN 2 MM IN MEDIAL DIRECTION. 54 MISPLACED SCREWS WITH BREACHING OF 2-4 MM IN LATERAL DIRECTION. 13 MISPLACED SCREWS WITH BREACHING OF 2-4 MM IN MEDIAL DIRECTION. 15 MISPLACED SCREWS WITH BREACHING OF MORE THAN 4 MM IN LATERAL DIRECTION. 6 MISPLACED SCREW WITH BREACHING OF NO MORE THAN 4 MM IN MEDIAL DIRECTION. DEPUY SPINE DEVICE: UNKNOWN EXPEDIUM SPINE SYSTEM SCREWS. IT CAPTURES THE REPORTED EVENT OF MISPLACEMENT OF SCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280848 UNKNOWN MONO/POLYAXIAL SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention