BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWS

    MDR report key: 4210470 · Received October 29, 2014

    Report

    Report Number
    2520274-2014-14032
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    May 24, 2011
    Report Date
    October 1, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DIENSTKNECHT T., ET AL (2011). A MINIMALLY INVASIVE STABILIZING SYSTEM FOR DORSAL PELVIC RING INJURIES. CLINICAL ORTHOPAEDICS & RELATED RESEARCH. 469 (11):3209-17. THIS REPORT IS FOR UNKNOWN PEDICLE SCREWS, UNKNOWN QUANTITY, AND UNKNOWN PART AND LOT NUMBERS. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT 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 DIENSTKNECHT T., ET AL (2011). A MINIMALLY INVASIVE STABILIZING SYSTEM FOR DORSAL PELVIC RING INJURIES. CLINICAL ORTHOPAEDICS & RELATED RESEARCH. 469 (11):3209-17. A RETROSPECTIVE STUDY WAS CONDUCTED TO REVIEW 67 PATIENTS WHO UNDERWENT MINIMALLY INVASIVE REDUCTION AND FIXATION OF A DORSAL PELVIC RING INJURY BETWEEN JANUARY 2000 AND DECEMBER 2007. OF THE 67 INJURIES, 16 WERE SACROILIAC DISPLACEMENTS AND 51 WERE SACRAL FRACTURES. SIXTY PATIENTS HAD MULTIPLE INJURIES AND SEVEN HAD ISOLATED PELVIC RING INJURIES ACCOMPANIED ONLY BY MINOR EXTREMITY INJURIES. SEVENTEEN PATIENTS HAD A COMPLEX PELVIC RING INJURY. THE PREDOMINANT INJURY MECHANISMS WERE MOTOR VEHICLE ACCIDENTS (30 OF 67) FOLLOWED BY FALLS FROM A HEIGHT (26 OF 67). THE MEAN PATIENT AGE AT THE TIME OF SURGERY WAS 36.7 YEARS (RANGE, 16¿76 YEARS). TWENTY-NINE PATIENTS WERE FEMALE, AND 38 WERE MALE. THE INDICATIONS FOR SURGERY WERE: (1) SACROILIAC DISPLACEMENT AND (2) SACRAL FRACTURES. FIVE OF THE 67 PATIENTS DID NOT COMPLETE FOLLOW-UP: TWO DIED DURING THE EARLY POSTOPERATIVE PERIOD (ONE OWING TO TRAUMATIC BRAIN INJURY AND THE OTHER FROM HEART FAILURE), AND THREE MOVED AWAY OR WERE NOT AVAILABLE FOR REEVALUATION OWING TO PERSONAL REASONS. THEREFORE, 62 PATIENTS WERE EVALUATED AT A MINIMUM OF 36 MONTHS (MEAN, 37 MONTHS; RANGE, 36¿42 MONTHS). DETERMINATION OF DISPLACEMENT WAS DONE BY GRADING THREE RADIOGRAPHIC VIEWS (ANTERIOR/POSTERIOR (AP), 40°-CAUDAD [INLET], AND 40°-CEPHALED [OUTLET]) OF THE PELVIS. USING A BONE AWL THE SURGEON OPENED THE CORTICAL BONE AND WIDENED THE OPENING PARALLEL TO THE LINE OF THE POSTERIOR GLUTEAL LINE UNTIL THE INSTRUMENT REACHED THE OPPOSING CORTEX. PEDICLE SCREWS (7 MM IN DIAMETER, UNIVERSAL SPINE SYSTEM (USS)) WERE THEN INSERTED, USUALLY WITH A LENGTH OF 50 MM TO 60 MM. THE SAME PROCEDURE WAS PERFORMED ON THE CONTRALATERAL SIDE. IN THE SAGITTAL PLANE, A NARROW ANGLE (<30°) WAS PREFERRED TO AVOID IMPLANT PROMINENCE AND SECONDARY SOFT TISSUE IRRITATION. THE CONNECTION BAR (6-MM DIAMETER, USS) THEN WAS INSERTED SUBFASCIALLY AND FIXED TO THE PEDICLE SCREWS. ACCORDING TO THE STRUCTURE OF THE FRACTURE, DISTRACTION OR COMPRESSION WAS APPLIED USING THE DISTRACTION/COMPRESSION DEVICE FROM THE USS. ANATOMIC REDUCTION AND SCREW POSITION THEN WERE CHECKED INTRAOPERATIVELY USING AP AND INLET/OUTLET VIEW RADIOGRAPHS. MANUAL CLOSED REDUCTION WAS PERFORMED. AT 1 YEAR AND AT THE LAST FOLLOW-UP, RADIOGRAPHS WERE OBTAINED, INCLUDING AP, 40°-CAUDAD, AND 40°-CEPHALAD PELVIC VIEWS. AT THE LAST FOLLOW-UP OF THE PATIENTS WITH ISOLATED PELVIC TRAUMA, 34 HAD ANATOMIC REDUCTION AND 12 HAD RESIDUAL DISPLACEMENT LESS THAN 5 MM. FOR PATIENTS WITH COMPLEX TRAUMA, 11 HAD ANATOMIC REDUCTION, FOUR HAD RESIDUAL DISPLACEMENT LESS THAN 5 MM, AND ONE HAD A GAP GREATER THAN 5 MM OWING TO IMPLANT FAILURE. FOUR WOUND INFECTIONS OCCURRED DURING THE FIRST 4 WEEKS POSTOPERATIVELY, ALL IN PATIENTS WITH POLYTRAUMA AND LONG-TIME VENTILATION. ONE MALPOSITIONED SCREW WAS IDENTIFIED WITHOUT ANY CONSEQUENCES TO THE HEALING PROCESS AND ONE SECONDARY DISPLACEMENT ATTRIBUTABLE TO IMPLANT FAILURE. TWO PATIENTS HAD DEEP VEIN THROMBOSIS WITH SECONDARY PULMONARY EMBOLUS. THIRTEEN PATIENTS HAD ACUTE RESPIRATORY DISTRESS SYNDROME. ONE PATIENT HAD AN ASYMPTOMATIC SCREW LOOSENING, WHICH WAS IDENTIFIED DURING IMPLANT EXPLANTATION. SEVEN PATIENTS HAD POSTTRAUMATIC NERVE LESIONS; 6 PATIENTS HAD POSTTRAUMATIC UROGENITAL LESIONS AND SEXUAL DYSFUNCTION. FOUR PATIENTS HAD WOUND INFECTIONS AND WERE TREATED APPROPRIATELY. THIS REPORT IS FOR AN UNKNOWN NUMBER OF PEDICLE SCREWS (7 MM IN DIAMETER). THIS IS REPORT 2 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692539 SCREWS HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention