BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM. 6.5MM POLYAXIAL SCREW

    MDR report key: 3955384 · Received July 24, 2014

    Report

    Report Number
    1526439-2014-11709
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 7, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE EXPEDIUM 6.5MM POLYAXIAL SCREW WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE SCREW BROKE AT THE TRANSITION ZONE BETWEEN THE POLYAXIAL BALL AND SHANK. FRACTURE ANALYSIS FOUND EVIDENCE OF STRIATIONS WHICH ARE INDICATIVE OF FATIGUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE EXPEDIUM SI POLYAXIAL SCREW WAS CONDUCTED ON THE SPECIFIC PRODUCT CODE FROM THE COMPLAINT FILE AS THE SCREW SHANK DIAMETER AND LENGTH AFFECTS THE STRESS PROFILE DURING ANATOMICAL LOADING AND THEREFORE IS NOT INDICATIVE OF THE FAMILY OR VICE VERSA. THIS ANALYSIS FOUND NO RELATED COMPLAINTS. THE ROOT CAUSE OF THE POST-OPERATIVE SCREW FRACTURE CANNOT BE POSITIVELY DETERMINED, HOWEVER FRACTURE ANALYSIS FOUND EVIDENCE OF FATIGUE STRIATIONS. NO CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO SYSTEMIC TREND HAS BEEN OBSERVED. ADDITIONALLY, NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THE FRACTURE ANALYSIS REPORT. THEREFORE, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    IT WAS REPORTED THAT APPROXIMATELY NINE MONTHS AGO, THE PATIENT HAD A L3-S1 LUMBAR FUSION WITH EXPEDIUM SI SCREWS AND CONCORDE BULLET INTER-BODY CAGES. EXPEDIUM 6.5 MM POLYAXIAL SCREWS WERE PLACED FROM L3-S1 WITH CONCORDE INTER-BODY CAGES AT L3/4 AND L5/S1. THE PATIENT RETURNED WITH BACK PAIN AND POST OP X-RAYS WERE TAKEN. THE SURGEON NOTED THAT THE TWO S1 SCREWS WERE BROKEN. A L3-S1 HARDWARE REMOVAL, REVISIONS OF FUSION AND RE-INSTRUMENTATION OF L3-S1 HARDWARE WAS SCHEDULED. ALL SCREWS WERE REMOVED AND THE TWO BROKEN EXPEDIUM POLYAXIAL SCREWS AT S1 SCREWS WERE REMOVED USING A TREPHINE AND BROKEN SCREW EXTRACTOR. A COMPETITOR¿S PEDICLE SCREW SYSTEM AS PUT IN DURING THE REVISION SURGERY. THE FOLLOWING MFG MEDWATCH REPORTS ARE BEING FILED FOR THE TWO BROKEN EXPEDIUM POLYAXIAL SCREWS AT LEVEL S1: 1526439-2014-11708, 1526439-2014-11709.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433393 EXPEDIUM. 6.5MM POLYAXIAL SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE RL155832

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCORDE BULLET CAGES