BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL LOCK-PL 2.4 STRAIG 30HO TI

    MDR report key: 3183592 · Received June 22, 2013

    Report

    Report Number
    2520274-2013-03556
    Event Type
    Injury
    Date Received
    June 22, 2013
    Date of Event
    November 25, 2011
    Report Date
    December 5, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K093772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE EVALUATION REVEALED THAT THE SCREW IS COMPLETELY STUCK IN THE PLATE AS COMPLAINED. THE PARTS CAN NOT BE DISASSEMBLED WITHOUT DESTRUCTIVE FORCES, WHICH WOULD DAMAGE THE THREADS. IN THIS CASE WE FOUND THAT THE THREAD FLANKS OF BONE THREAD ARE COMPLETELY FLATTENED. THIS MAKES A DETERMINATION OF THE EXACT CAUSE OF THIS OCCURRENCE IMPOSSIBLE. IT IS KNOWN THAT EXCESSIVE FORCE WHILE INSERTING THE SCREW CAN LEAD TO A DAMAGE OF THE THREAD AND FINALLY TO A BLOCKAGE. BASED ON THE PROVIDED INFORMATION IT IS IMPOSSIBLE TO DETERMINE IF THIS DID HAPPEN DURING THE INSERTION, BY AN EXCESSIVE METALLIC CONTACT OR DURING EXTRACTION TOGETHER WITH THE PLATE. THE COMPLAINT HISTORY RECORDS OF THE PLATE AND SCREW WERE REVIEWED AND NO SIMILAR COMPLAINT WAS FOUND. REGRETTABLY A REVIEW OF THE MANUFACTURING DOCUMENTS IS NOT POSSIBLE AS THE ARTICLE NUMBER AND LOT NUMBER WERE CUT AWAY DURING THE PREPARATION OF THE PLATE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCKING SCREW IS STUCK IN THE PLATE, AND IT NEEDED TO BE REMOVED INTEROPERATIVELY. HE REMOVED THE PLATE WITH THE SCREW.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284091 STERNAL LOCK-PL 2.4 STRAIG 30HO TI HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention