BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3844238 · Received June 2, 2014

    Report

    Report Number
    0002249697-2014-02019
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K973164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. HOSPITAL REFUSED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) INCHES IN HEIGHT. CORRECTED PRODUCT INFORMATION BASED ON ADDITIONAL INFORMATION. SALES REP CALLED AND CONFIRMED THAT THE INFORMATION HE PROVIDED WAS FOR THE COMPONENT WHICH WAS IMPLANTED. HE DID NOT HAVE DEVICE DETAILS FOR THE EXPLANTED DEVICE. AN EVENT REGARDING A FRACTURE AND DISSOCIATED LOCKING SCREW FROM AN UNKNOWN DURACON TS INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. ONE LOW RESOLUTION OF THE EXPLANTED COMPONENTS WAS PROVIDED. THE FIXATION SCREW APPEARS TO BE FRACTURED. INSPECTION OF THE PROVIDED IMAGE CONFIRMED THE LOCKING SCREW WAS FRACTURED. NOTHING REGARDING THE NATURE OF THE FRACTURE COULD BE LEARNED FROM THE IMAGE. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED RECORDS WERE REJECTED FOR REVIEW BY A CONSULTING CLINICIAN. X-RAYS AND THE PATIENT'S CLINICAL HISTORY WOULD BE REQUIRED TO PROVIDE A MEANINGFUL DICTATION FOR THIS CASE. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED SCREW FRACTURE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED.

    Description of Event or Problem · 1

    WHEN THE SURGEON DID A REVISION TODAY OF A DURCON TOTAL STABILIZER HE FOUND THE SCREW HAD BACKED OUT, SO HE REMOVED THE INSERT AND OLD SCREW AND REPLACED IT WITH A NEW INSERT AND SCREW.

    Description of Event or Problem · 1

    WHEN THE SURGEON DID A REVISION TODAY OF A DURCON TOTAL STABILIZER, HE FOUND THE SCREW HAD BACKED OUT SO HE REMOVED THE INSERT AND OLD SCREW AND REPLACED IT WITH A NEW INSERT AND SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322286 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R