BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIS CANN POLY SCW 7X35MM,TI

    MDR report key: 3557280 · Received January 7, 2014

    Report

    Report Number
    1526439-2013-37166
    Event Type
    Injury
    Date Received
    January 7, 2014
    Date of Event
    December 12, 2013
    Report Date
    December 12, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK111136
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION NOTED THAT THE SCREW HAD FRACTURED IN THE TRANSITION AREA BETWEEN THE FLEX BALL AND THE SHANK. THE SCREW WAS SENT TO THE LAB FOR FRACTURE ANALYSIS. A SCANNING ELECTRON MICROSCOPY ANALYSIS WAS PERFORMED ON THE FRACTURED SURFACE TO FACILITATE A MORE DETAILED INVESTIGATION OF THE FRACTURE CHARACTERISTICS OF THE PART. THE SCREW¿S FRACTURED SURFACE EXHIBITED SMOOTH AND GRAINY/ROUGH REGIONS, INDICATIVE OF FATIGUE FAILURE. THE EXISTENCE OF TWO SURFACE MORPHOLOGIES IMPLIES THAT THE FRACTURE FIRST PROPAGATED AND THEN FULL FAILURE/BREAKAGE (ROUGH REGION) TOOK PLACE PRESUMABLY WHEN THE REMAINING REGION DID NOT HAVE STRENGTH TO BEAR THE LOAD. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE MIS CANN POLY SCW 7X35MM,TI FOUND NO DISCREPANCIES DURING THE MANUFACTURING OF THE PRODUCT. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE BEEN CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPANYING ALL QUALITY REQUIREMENTS. A 12 MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE MIS CANN POLY SCW 7X35MM,TI WAS CONDUCTED. THE ANALYSIS WAS ONLY CONDUCTED ON THE PRODUCT CODE BECAUSE ANY CHANGE IN DIAMETER OR LENGTH OF THE SCREW WOULD CHANGE THE FORCES PUT ON THE SCREW. REVIEW OF COMPLAINTS FOUND NO SIGNIFICANT TRENDS. THE ROOT CAUSE FOR THE MIS CANN POLY SCW 7X35MM,TI IS MOST LIKELY THE RESULT OF THE PSEUDOARTHROSIS, BASED ON THE FRACTURE ANALYSIS SHOWING FAILURE CONSISTENT WITH MATERIAL FATIGUE AND THE SURGEON EVALUATION OF PSEUDOARTHROSIS. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS REQUIRED AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE, AND THERE HAVE BEEN NO SYSTEMATIC TRENDS. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    PATIENT INHERITED FROM ANOTHER PHYSICIAN. SCREW BROKE FROM FATIGUE DUE TO PSEUDOARTHROSIS - LACK OF ANTERIOR SUPPORT. PHYSICIAN RECOGNIZED THIS AS THE CAUSE. REPLACED CONSTRUCT AND PROVIDED ANTERIOR SUPPORT WITH TRANSVERTEBRAL FIBULAR STRUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9685 MIS CANN POLY SCW 7X35MM,TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE ANDCTM

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention