BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5825451 · Received July 27, 2016

    Report

    Report Number
    2520274-2016-13680
    Event Type
    Injury
    Date Received
    July 27, 2016
    Date of Event
    July 26, 2013
    Report Date
    July 22, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN PART AND LOT OF A UNKNOWN QUANTITY OF LAG SCREWS. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: WUNG, C. C., AND W. J. CHEN. "ONE-STAGE REVISION SURGERY TO TREAT HIP INFECTED NONUNION AFTER STABILIZATION WITH A SLIDING COMPRESSION SCREW." ARCH ORTHOP TRAUMA SURG 123 (2003): 383-87. TAIWAN. THIRTEEN CONSECUTIVE PATIENTS WHO SUSTAINED AN EXTRACAPSULAR HIP INFECTED NONUNION AFTER STABILIZATION WITH A SLIDING HIP SCREW (SCS) WERE TREATED WITH REMOVAL OF SCS, LOCAL RADICAL DEBRIDEMENT, VANCOMYCIN POWDER WITH OR WITHOUT GENTAMICIN SOLUTION APPLICATION, RE-INSERTION OF A NEW SCS, AND AUTOGENOUS CANCELLOUS BONE GRAFTING. AFTER CANCELLOUS BONE GRAFT WAS PACKED IN THE TUNNEL OF THE PRIOR LAG SCREW, A NEW LAG SCREW (SYNTHES) WAS INSERTED AT THE DESIGNED LOCATION. ONLY ONE PATIENT HAD FLARE-UP OF THE INFECTION AT 2 MONTHS. THIS PATIENT ALSO HAD A 5.5 CM OF FEMORAL SHORTENING. AT THE SECOND ADMISSION, LOCAL AREA WAS DEBRIDED AGAIN AND IRRIGATED WITH MASSIVE NORMAL SALINE SOLUTION. VANCOMYCIN POWDER WAS PLACED IN THE WOUND ACCORDING TO THE FIRST CULTURE DATA (PURE ORSA). THIS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN SCREW LAG SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478860 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention