BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI PEDICLE SCREW

    MDR report key: 2111217 · Received April 12, 2011

    Report

    Report Number
    3004774118-2011-00007
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 11, 2011
    Manufacturer
    K2M, INC.
    Product Code
    KWP
    PMA / PMN Number
    K042635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION WAS COMPLETED AS THE LOT NUMBER HAS BEEN IDENTIFIED/CONFIRMED IN THIS CASE. SINCE THE SET SCREW HAS BEEN DISCARDED, NO PHYSICAL EVALUATION COULD BE PERFORMED, AND THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. A REVIEW OF APPLICABLE MATERIAL, INSPECTION, MANUFACTURING, AND DISTRIBUTION RECORDS OF POSSIBLE DEVICE MANUFACTURING DATES ACCORDING TO THE DESCRIPTION OF THE PRODUCTS USED WITH THE CONCOMITANT DEVICE(S) WAS CONDUCTED. ALL RECORDS REVEALED THAT ALL PRODUCTS LOTS WERE MANUFACTURED WITHIN SPECIFICATIONS AND DISTRIBUTED IN ACCORDANCE WITH ALL OPERATING PROCEDURES. A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS DID NOT REVEAL ANY CONTRIBUTING INFORMATION/TRENDS. ACCORDING TO THE APPLICABLE PRODUCT LINE RISK RELATED DOCUMENTS, K2M HAS IDENTIFIED THAT THE SET SCREW MAY HAVE BACKED OUT DUE TO INSUFFICIENT OR OVER TORQUING, INCORRECT ROD LENGTH, MISALIGNMENT OF SET SCREW, ETC. SEVERAL OTHER CAUSES WHICH MAY HAVE BEEN CONTRIBUTED TO THIS ISSUE COULD BE INAPPROPRIATE ACTIVITY DURING RECOVERY, PREEXISTING CONDITIONS, AS IDENTIFIED IN THE IFU. A REVIEW OF ALL APPLICABLE RISK RELATED DOCUMENTS REVEALED THAT K2M ADDRESSES POTENTIAL SET SCREW BACK OUT CONCERNS RAISED IN THIS COMPLAINT, THEREFORE NO ADDITIONAL HAZARDS REQUIRED. CURRENT SEVERITY AND FREQUENCY VALUES ARE SATISFACTORY AND NO CHANGES ARE DEEMED NECESSARY. A REVIEW OF THE COMPLAINT TRENDS RELATED TO THIS SET SCREW AND BACK OUT DID NOT REVEAL ANY CONTRIBUTING INFORMATION.

    Additional Manufacturer Narrative · 1

    DETAILS SURROUNDING THE CASE ARE STILL BEING OBTAINED. THE SURGEON WAS REPORTEDLY GOING IN TO REMOVE A SCREW WHICH WAS PREVIOUSLY IMPLANTED A FEW DAYS PRIOR BUT THOUGHT TO BE TOO LONG. THERE IS SOME SUGGESTIONS THAT THE SURGEON PLANNED TO REPLACE THE LONG SCREW FROM THE ONSET BUT COULD NOT DUE TO SOME HEALTH ISSUES THE PT HAD. THE CONDITION RESULTING IN THE DELAY OF REPLACING THE SCREWS REMAINS UNK TO DATE. THE PT REPORTEDLY DEVELOPED A HEMATOMA BUT THIS (AND THE CAUSE) HAVE ALSO NOT BEEN CONFIRMED. PRE-REVISION X-RAYS HAVE BEEN REQUESTED, AS WELL AS THE PART. IT IS UNCERTAIN WHETHER OR NOT THE PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. IF IT IS REC'D AND ANALYZED, ALONG WITH THE INSTRUMENTS USED IN THE INITIAL CASE, THE FINDINGS WILL BE PROVIDED AS A SUPPLEMENT TO THIS REPORT.

    Description of Event or Problem · 1

    SURGEON REPORTEDLY WENT IN TO REVISE A PEDICLE SCREW WHICH HE BELIEVES WAS TOO LONG FROM THE OUTSET AND WHEN HE OPENED UP THE PT TO CHANGE THE SCREW, HE NOTICED THE SET SCREW HAD LOOSENED OR POPPED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENALI PEDICLE SCREW PEDICLE SCREW KWP K2M, INC. NA JKB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention