BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5603697 · Received April 25, 2016

    Report

    Report Number
    2520274-2016-12233
    Event Type
    Injury
    Date Received
    April 25, 2016
    Report Date
    April 21, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS LITERATURE CITATION:LEIGHTON, R.K (2015). "ARE LOCKING CONSTRUCTS IN DISTAL FEMORAL FRACTURES ALWAYS BEST? A PROSPECTIVE MULTICENTER RANDOMIZED CONTROLLED TRIAL COMPARING THE LESS INVASIVE STABILIZATION SYSTEM WITH THE MINIMALLY INVASIVE DYNAMIC CONDYLAR SCREW SYSTEM.¿ J. ORTHOP TRAUMA (2016) 30: E1-E6. (B)(6) ARTICLE. THIS REPORT IS FOR UNKNOWN SCREWS, UNKNOWN QUANTITY, UNKNOWN LOT, 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, LEIGHTON, R.K (2015). "ARE LOCKING CONSTRUCTS IN DISTAL FEMORAL FRACTURES ALWAYS BEST? A PROSPECTIVE MULTICENTER RANDOMIZED CONTROLLED TRIAL COMPARING THE LESS INVASIVE STABILIZATION SYSTEM WITH THE MINIMALLY INVASIVE DYNAMIC CONDYLAR SCREW SYSTEM." J. ORTHOP TRAUMA (2016) 30: E1-E6. (B)(6) ARTICLE. THE PURPOSE OF THE CLINICAL STUDY WAS TO DETERMINE WHETHER THE RATE OF FRACTURE HEALING AND FRACTURE UNION, REPAIRED WITH A LOCKED DEVICE WILL BE AS GOOD OR BETTER THAN STANDARD NONLOCKING FIXATION IN DISTAL FEMORAL FRACTURES. FIFTY-TWO PATIENTS WITH DISTAL FEMORAL FRACTURES WERE INITIALLY ENROLLED IN THE STUDY. PATIENTS WERE TREATED WITH EITHER THE LOCKED LESS INVASIVE STABILIZATION SYSTEM (LISS) OR THE DYNAMIC CODYLAR SCREW (DCS); 28 WERE TREATED WITH LISS PLATE AND 24 WERE TREATED WITH DCS. THE FOLLOWING WERE NOTED AS COMPLICATIONS FOR BOTH SYSTEMS. -2 DEATHS SEVERAL MONTHS POST-OPERATIVELY; DUE TO PNEUMONIA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE -1 CASE OF PULMONARY EMBOLISM -1 CASE OF ARTHOFIBROSIS OF THE KNEE; TREATED WITH ARTHROSCOPY AND MANIPULATION. -2 CASES OF DEEP INFECTION TREATED WITH IV ANTIBIOTICS, AND HEMOVAC AND DEBRIDEMENT RESPECTIVELY -2 CASES OF FRACTURES THAT DRIFTED INTO VARUS ANGULATION; NO REVISION IN EITHER CASE -11 CASES OF NON UNION, MAL UNION, AND OR LOSS OF REDUCTION WITH REVISION SURGERIES -2 CASES OF PAIN AND IMPLANT PROMINENCE POST HEALING THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN SCREWS FOR BOTH LISS AND DCS SYSTEMS A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260216 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention