BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-M 1.6MM BEADED CABLE SET VIT

    MDR report key: 4093853 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03499
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    March 10, 2008
    Report Date
    August 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDQ
    PMA / PMN Number
    K953818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING IMPLANT MIGRATION INVOLVING A D-M 1.6MM BEADED CABLE SET VIT WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW WITH A CLINICAL CONSULTANT INDICATED: THE LONG TIME INTERVAL BEFORE SECONDARY INTERVENTION WITH DYNAMIZATION OF THE FRACTURE AND INTENT AT CABLE REMOVAL GIVING THE CABLE AMPLE TIME FOR BECOMING EMBEDDED IN BONE PLUS THE FACT THAT ONLY THE SLEEVE WAS REMOVED AND NOT THE CABLE ITSELF ALLOWING THE BRAIDED WIRE FILAMENTS TO START TO MIGRATE INTO THE WOUND ENVIRONMENT. THIS WAS ALREADY A FACT AT THE TIME OF THE REMOVAL PROCEDURE IN 2008 AND ONLY BECAME WORSE AFTER THAT. BETTER EFFORTS AT MORE COMPLETE CABLE REMOVAL DID NOT APPEAR TOO DIFFICULT GIVEN THE LONG FRAYED FREE FLOATING CABLE END VISIBLE ON X-RAY. EVEN IF NOT ALL OF THE CABLE COULD HAVE BEEN REMOVED, ALL CABLE OUTSIDE THE BONE INGROWTH AREA SHOULD HAVE BEEN REMOVED TO PREVENT THE FRAYED CABLE END CAUSING THE TROUBLE IT DID IN THIS CASE. CONCLUSIONS: THE ROOT CAUSE OF THE EVENT WAS REMOVAL OF THE SLEEVE WITHOUT REMOVAL OF THE CORRESPONDING CABLE RESULTING IN A FREE FLOATING FRAYED CABLE AND MIGRATION OF THE WIRE FILAMENTS. THERE IS NO EVIDENCE THAT THE EVENT WAS MATERIAL OR MANUFACTURING RELATED.

    Description of Event or Problem · 1

    WE RECEIVED A LETTER FROM THE ATTORNEY OF THE PATIENT THAT PIECES OF THE CERCLAGE CABLES ARE DISPLACED AND MOVING AROUND. SINCE THE THIRD SURGERY THE PATIENT HAS PAIN AND RECEIVED SOME MORE SURGERIES.

    Description of Event or Problem · 1

    WE RECEIVED A LETTER FROM THE ATTORNEY OF THE PATIENT THAT PIECES OF THE CERCLAGE CABLES ARE DISPLACED AND MOVING AROUND. SINCE THE THIRD SURGERY THE PATIENT HAS PAIN AND RECEIVED SOME MORE SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571571 D-M 1.6MM BEADED CABLE SET VIT IMPLANT JDQ STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention