BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 19282969 · Received May 9, 2024

    Report

    Report Number
    0009617544-2024-00084
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    January 1, 2016
    Report Date
    September 17, 2024
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE LOCATION UNKNOWN.

    Description of Event or Problem · 0

    THE ARTICLE 'EFFECT OF THE SUBCUTANEOUS ROUTE FOR ILIAC SCREW INSERTION IN LUMBOPELVIC FIXATION FOR VERTICAL UNSTABLE SACRAL FRACTURES ON THE INFECTION RATE: A RETROSPECTIVE CASE SERIES' IN INJURY, INT. J. CARE INJURED 47 (2016) 2212¿2217, WAS REVIEWED. BETWEEN JANUARY 2012 AND DECEMBER 2013, 28 CONSECUTIVE PATIENTS WITH VERTICAL UNSTABLE SACRAL FRACTURES UNDERWENT LUMBOPELVIC FIXATION UTILIZING THE XIA SYSTEM. ALL PATIENTS WERE ADMITTED TO THE HOSPITAL THROUGH THE EMERGENCY DEPARTMENT. THE STUDY EVALUATED THE SURGICAL, RADIOGRAPHIC, AND FUNCTIONAL OUTCOMES OF SEVERAL APPROACHES. THE SURGERY OUTCOME EVALUATION WAS BASED ON THE POSTOPERATIVE MEDICAL RECORDS. DURING THE STUDY PERIOD, 28 PATIENTS WITH VERTICAL UNSTABLE SACRAL FRACTURES WERE INCLUDED. THERE WERE 8 MEN AND 19 WOMEN WITH A MEAN AGE OF 33.8 YEARS (RANGE, 17 TO 54 YEARS). THE MAIN TRAUMATIC MECHANISM FOR SACRAL FRACTURE WAS A FALL FROM HEIGHT (N = 15), FOLLOWING BY A MOTOR VEHICLE COLLISION (N = 12) AND BLUNT TRAUMA BY AN AUTOMATIC MACHINE (N = 1). ALL PATIENTS HAD POLYTRAUMA, AND THE MEAN INJURY SEVERITY SCORE WAS 19.5 (RANGE, 9¿50). THE TWO MOST COMMON CONCOMITANT INJURIES WERE LUMBAR SPINAL FRACTURE (N = 26) AND LIMB FRACTURE (N = 21). THIRTEEN PATIENTS WERE SENT TO THE ANGIOGRAPHY SUITE FOR TRANSARTERIAL EMBOLIZATION (TAE) AS A HEMOSTASIS PROCEDURE. THE MEAN TIME FROM THE EMERGENCY ROOM TO THE ANGIOGRAPHY SUITE WAS 192 MIN (RANGE, 62¿240 MIN). NO PATIENTS UNDERWENT PREPERITONEAL PELVIC PACKING OPERATION OR REPEAT TAE AFTER THE FIRST TAE PROCEDURE. SEVENTEEN PATIENTS COMPLETED THE MAJEED SCORE EVALUATION 1 YEAR POSTOPERATIVELY. THE MEAN MAJEED SCORE WAS 84.5 (RANGE: 64¿99). INCOMPLETE DATA FROM THE REMAINING 11 PATIENTS RESULTED FROM THE MISSING SCORE FOR THE SEXUAL INTERCOURSE ITEM. AT THE TIME OF INJURY, 14 PATIENTS PRESENTED WITH VARYING DEGREES OF A LUMBOSACRAL PLEXUS INJURY, AND 2 HAD COMPLETE CAUDA EQUINA SYNDROME. TEN PATIENTS RECOVERED FULLY AFTER 1-YEAR FOLLOW-UP, AND 4 HAD RESIDUAL PARTIAL MOTOR DYSFUNCTION. THE 2 PATIENTS WITH CAUDA EQUINA SYNDROME STILL HAD LUMBOSACRAL NERVE PLEXUS DYSFUNCTION. ALL THE FRACTURES WERE UNITED AT THE 12-MONTH FOLLOW-UP, EVEN THOUGH 1 PATIENT HAD A BROKEN CONNECTION ROD AND 1 PATIENT HAD A LOOSED ILIAC SCREW. THIS REPORT CAPTURES THE ONE PATIENT WHO EXPERIENCED A BROKEN ROD.

    Description of Event or Problem · 0

    THE ARTICLE 'EFFECT OF THE SUBCUTANEOUS ROUTE FOR ILIAC SCREW INSERTION IN LUMBOPELVIC FIXATION FOR VERTICAL UNSTABLE SACRAL FRACTURES ON THE INFECTION RATE: A RETROSPECTIVE CASE SERIES' IN INJURY, INT. J. CARE INJURED 47 (2016) 2212¿2217, WAS REVIEWED. BETWEEN JANUARY 2012 AND DECEMBER 2013, 28 CONSECUTIVE PATIENTS WITH VERTICAL UNSTABLE SACRAL FRACTURES UNDERWENT LUMBOPELVIC FIXATION UTILIZING THE XIA SYSTEM. ALL PATIENTS WERE ADMITTED TO THE HOSPITAL THROUGH THE EMERGENCY DEPARTMENT. THE STUDY EVALUATED THE SURGICAL, RADIOGRAPHIC, AND FUNCTIONAL OUTCOMES OF SEVERAL APPROACHES. THE SURGERY OUTCOME EVALUATION WAS BASED ON THE POSTOPERATIVE MEDICAL RECORDS. DURING THE STUDY PERIOD, 28 PATIENTS WITH VERTICAL UNSTABLE SACRAL FRACTURES WERE INCLUDED. THERE WERE 8 MEN AND 19 WOMEN WITH A MEAN AGE OF 33.8 YEARS (RANGE, 17 TO 54 YEARS). THE MAIN TRAUMATIC MECHANISM FOR SACRAL FRACTURE WAS A FALL FROM HEIGHT (N = 15), FOLLOWING BY A MOTOR VEHICLE COLLISION (N = 12) AND BLUNT TRAUMA BY AN AUTOMATIC MACHINE (N = 1). ALL PATIENTS HAD POLYTRAUMA, AND THE MEAN INJURY SEVERITY SCORE WAS 19.5 (RANGE, 9¿50). THE TWO MOST COMMON CONCOMITANT INJURIES WERE LUMBAR SPINAL FRACTURE (N = 26) AND LIMB FRACTURE (N = 21). THIRTEEN PATIENTS WERE SENT TO THE ANGIOGRAPHY SUITE FOR TRANSARTERIAL EMBOLIZATION (TAE) AS A HEMOSTASIS PROCEDURE. THE MEAN TIME FROM THE EMERGENCY ROOM TO THE ANGIOGRAPHY SUITE WAS 192 MIN (RANGE, 62¿240 MIN). NO PATIENTS UNDERWENT PREPERITONEAL PELVIC PACKING OPERATION OR REPEAT TAE AFTER THE FIRST TAE PROCEDURE. SEVENTEEN PATIENTS COMPLETED THE MAJEED SCORE EVALUATION 1 YEAR POSTOPERATIVELY. THE MEAN MAJEED SCORE WAS 84.5 (RANGE: 64¿99). INCOMPLETE DATA FROM THE REMAINING 11 PATIENTS RESULTED FROM THE MISSING SCORE FOR THE SEXUAL INTERCOURSE ITEM. AT THE TIME OF INJURY, 14 PATIENTS PRESENTED WITH VARYING DEGREES OF A LUMBOSACRAL PLEXUS INJURY, AND 2 HAD COMPLETE CAUDA EQUINA SYNDROME. TEN PATIENTS RECOVERED FULLY AFTER 1-YEAR FOLLOW-UP, AND 4 HAD RESIDUAL PARTIAL MOTOR DYSFUNCTION. THE 2 PATIENTS WITH CAUDA EQUINA SYNDROME STILL HAD LUMBOSACRAL NERVE PLEXUS DYSFUNCTION. ALL THE FRACTURES WERE UNITED AT THE 12-MONTH FOLLOW-UP, EVEN THOUGH 1 PATIENT HAD A BROKEN CONNECTION ROD AND 1 PATIENT HAD A LOOSED ILIAC SCREW. THIS REPORT CAPTURES THE ONE PATIENT WHO EXPERIENCED A BROKEN ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771480 UNKNOWN_SPINE_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown