BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAP, BONE

    MDR report key: 5853117 · Received August 8, 2016

    Report

    Report Number
    2520274-2016-13946
    Event Type
    Injury
    Date Received
    August 8, 2016
    Report Date
    July 23, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBCAPITAL CORRECTION OSTEOTOMY IN SLIPPED CAPITAL FEMORAL EPIPHYSIS BY MEANS OF SURGICAL HIP DISLOCATION. OPERATIVE ORTHOPÄDIE UND TRAUMATOLOGIE (2007) 4: 389-410. (SWITZERLAND). THIS REPORT IS FOR UNKNOWN SCREW/ UNKNOWN QUANTITY/ UNKNOWN LOT. UDI: PART NUMBER UNKNOWN, UDI NUMBER 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: LEUNIG, MICHAEL, SLONGO, THEDDY, KLEINSCHMIDT, MARK, AND GANZ, REINHOLD (2007). SUBCAPITAL CORRECTION OSTEOTOMY IN SLIPPED CAPITAL FEMORAL EPIPHYSIS BY MEANS OF SURGICAL HIP DISLOCATION. 4: 389-410. (SWITZERLAND). THIS ARTICLE DISCUSSED A TREATMENT TO ANATOMICALLY ALIGN EPIPHYSIS WITH NORMAL BLOOD SUPPLY FOR A SLIPPED CAPITAL FEMORAL EPIPHYSIS BY USING A TECHNIQUE WHICH OPEN SUBCAPITAL REORIENTATION OF THE EPIPHYSIS OR BY WEDGE OSTEOTOMY OF THE FEMORAL NECK. FROM 1996 TO 2005, 30 HIPS WITH A DIAGNOSIS OF SLIPPED CAPITAL FEMORAL EPIPHYSIS WERE TREATED ACCORDING TO THE TECHNIQUE DESCRIBED. SUBCAPITAL REORIENTATION WAS PERFORMED ON 30 HIPS IN 30 PATIENTS WITH CLASSIC SLIPPED CAPITAL FEMORAL EPIPHYSIS. TWENTY-THREE (23) OPERATIONS WERE PERFORMED ON THE LEFT HIP AND ONLY SEVEN ON THE RIGHT. THE AGE AT TIME OF SURGERY WAS BETWEEN 10 AND 17 YEARS, GIRLS WERE ON AVERAGE 12 YEARS AND BOYS 14 YEARS OLD.. COMPLICATIONS: TWO HIPS REQUIRED REVISION DUE TO SCREW FAILURE. THIS COMPLAINT CONTAINS ONE DEVICE. THIS COMPLAINT IS FOR AN UNKNOWN AO SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506472 TAP, BONE HWX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention