BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT JAVA POLYAXIAL PEDICLE SCREW DG 40

    MDR report key: 5786169 · Received July 12, 2016

    Report

    Report Number
    3003853072-2016-00104
    Event Type
    Injury
    Date Received
    July 12, 2016
    Date of Event
    May 2, 2016
    Report Date
    May 27, 2016
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK111301
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. TWO LOTS WERE RETURNED THAT WERE NOT REPORTED, THEREFORE INITIAL REPORTS 3003853072-2016-00103 AND 3003853072-2016-00104 WERE SUBMITTED. REFERENCE SUPPLEMENTAL REPORTS 3003853072-2016-00060-1 THROUGH 3003853072-2016-00064-1.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED WITH THE RETURNED CONSTRUCT PARTS AND THE INFORMATION AVAILABLE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT FIND ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER, AS THE HARDNESS AND MICROGRAPHIC STRUCTURE WERE TESTED AND SHOWN TO BE PERFECTLY CONSISTENT WITH A TA6VTYPE TITANIUM ALLOY, IT IS LIKELY THAT THE DEVICE BROKE FOLLOWING A PHENOMENON OF PROGRESSIVE CRACKING ATTRIBUTABLE TO REPEATED CYCLIC FLEXION.

    Description of Event or Problem · 1

    SINCE (B)(6) 2015, THE PATIENT HAD BEGUN EXPERIENCING INCREASING LOW BACK PAIN. ON (B)(6) 2016, IT IS NOTED IN AN OFFICE NOTE THAT THERE IS EVIDENCE OF A BROKEN SCREW. NO SPECIFIC OCCURRENCES (E.G. TRAUMA, NON-COMPLIANCE) ARE RELATED TO THIS OCCURRING. THE PATIENT'S BONE QUALITY AND CURRENT STATUS/CONDITION WAS NOT INDICATED. IT IS REPORTED FUSION DID NOT OCCUR. NO X-RAYS OR SURGICAL REPORT ARE AVAILABLE AT THIS TIME. INDICATION OF THE INITIAL SURGERY DEGENERATIVE DISC AT LUMBAR 4-5, 5-SACRAL 1 WITH SPONDYLOLISTHESIS. DESCRIPTION OF THE CONSTRUCT IMPLANTED DURING THE INITIAL SURGERY. LUMBAR 4-5-SACRAL 1 PEDICLE SCREWS WITH CROSS CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441206 INSTINCT JAVA POLYAXIAL PEDICLE SCREW DG 40 SCREW NKB ZIMMER SPINE N/A H23491E

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R