BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5885754 · Received August 18, 2016

    Report

    Report Number
    2520274-2016-14191
    Event Type
    Injury
    Date Received
    August 18, 2016
    Report Date
    July 27, 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 USED FOR TREATMENT, NOT DIAGNOSIS. ¿ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING QUADRICEPS TENDON AUTOGRAFT FOR ADOLESCENTS WITH OPEN PHYSES- A TECHNICAL NOTE.¿ (2011) MAUCH, C., ARNOLD, M.P., WIRRIES, A., MAYER, R.R., NIKLAUS, F.F., AND HIRSCHMANN, M.T. SPORTS MEDICINE, ARTHROSCOPY, REHABILITATION, THERAPY & TECHNOLOGY 3:7. THIS REPORT IS FOR AN UNKNOWN 3.5 MM MODIFIED CORTICAL SCREW /UNKNOWN QUANTITY/UNKNOWN LOT. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    REPORT SHOULD NOT BE OTHER SERIOUS (IMPORTANT MEDICAL EVENTS). 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: MAUCH, C., ARNOLD, M.P., WIRRIES, A., MAYER, R.R., NIKLAUS, F.F., AND HIRSCHMANN, M.T. (2011) ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING QUADRICEPS TENDON AUTOGRAFT FOR ADOLESCENTS WITH OPEN PHYSES- A TECHNICAL NOTE. SPORTS MEDICINE, ARTHROSCOPY, REHABILITATION, THERAPY & TECHNOLOGY 3:7. SWITZERLAND. THE PRIMARY PURPOSE OF THIS ARTICLE IS TO DESCRIBE THE TECHNIQUE OF A TRANSPHYSEAL ACL RECONSTRUCTION USING QUADRICEPS TENDON-BONE AUTOGRAFT IN CHILDREN AND ADOLESCENTS WITH OPEN GROWTH PLATES. THE SECONDARY AIM IS TO REPORT OUR EARLY RESULTS IN TERMS OF POSTOPERATIVE GROWTH DISTURBANCES WHICH ARE CONSIDERED TO BE A MAJOR CONCERN IN THIS CHALLENGING GROUP OF PATIENTS. FROM JANUARY 1997 TO DECEMBER 2007, 49 CONSECUTIVE CHILDREN AND ADOLESCENTS WITH OPEN GROWTH PLATES WERE TREATED FOR A TORN ACL USING THE AFOREMENTIONED SURGICAL TECHNIQUE. THE PATIENTS (28 MALES AND 21 FEMALES) WITH A MEDIAN AGE AT SURGERY OF 13 (RANGE 8-15) YEARS WERE RETROSPECTIVELY EVALUATED. A 3.5 MM POST SCREW (MODIFIED CORTICAL SCREW WITH LONG NECK, SYNTHES, (B)(4)) WAS PLACED INTO THE DISTAL FEMUR. FIVE OF THE PATIENTS UNDERWENT REVISION ACL SURGERY DUE TO ANOTHER ADEQUATE SPORTS TRAUMA AFTER THE GROWTH-STOP. TEN PATIENTS HAD TO HAVE THE TIBIAL FIXATION SCREW REMOVED UNDER LOCAL ANAESTHESIA . THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN 3.5 MM MODIFIED CORTICAL SCREW WITH LONG NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539467 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R