BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 4778237 · Received May 18, 2015

    Report

    Report Number
    2520274-2015-13914
    Event Type
    Injury
    Date Received
    May 18, 2015
    Report Date
    April 27, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    PK962011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). DATE OF EVENT IS UNKNOWN (FOR THE DATE PATIENT STARTED TO EXPERIENCE PAIN AND OTHER SYMPTOMS OF DISCOMFORT). THIS REPORT IS FOR THREE UNKNOWN 7.3MM CANNULATED SCREWS. ONLY A PARTIAL PART NUMBER, 209.8 WAS REPORTED. THIS PARTIAL NUMBER CORRESPONDS TO PART FAMILY 209.8XX WHICH INCLUDES THE FOLLOWING SCREWS: PARTIAL BRAND NAME 7.3MM CANNULATED SCREW 32MM THREAD (VARIOUS LENGTHS), 510(K) K962011, DEVICE PRODUCT CODE HWC. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 DUE TO PROMINENCE AND PAIN. THREE, UNKNOWN 7.3MM CANNULATED SCREWS, ORIGINALLY IMPLANTED ON (B)(6) 2014, WERE REMOVED FROM THE SACROILIAC JOINT AND THE RIGHT ACETABULUM. ADDITIONALLY REMOVED WERE TWO DISTAL SCREWS FROM A LATERAL ENTRY FEMORAL RECON NAIL; THESE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2014. IT WAS REPORTED THAT THE SURGERY WAS SUCCESSFULLY COMPLETED AND THAT THE PATIENT¿S POSTOPERATIVE STATUS WAS "GOOD". THIS REPORT IS FOR THREE UNKNOWN 7.3MM CANNULATED SCREWS. THIS REPORT IS 1 OF 2 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322436 SCREW,FIXATION,BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention