BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACTION, COMPONENT, INVASIVE

    MDR report key: 3899302 · Received June 27, 2014

    Report

    Report Number
    2520274-2014-12169
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JEC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. TREATMENT OF UNSTABLE PELVIC RING INJURIES WITH AN INTERNAL ANTERIOR FIXATOR AND POSTERIOR FIXATION: INITIAL CLINICAL SERIES, VAIDYA, R., COLEN, R., VIGDORCHIK, J., TONNOS, F., AND SETHI, A. J. ORTHOP & TRAUMA: SURGERY 2012; 26:1-8. THIS REPORT IS FOR AN UNKNOWN SPINE (C-RINGS). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    (B)(4).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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TREATMENT OF UNSTABLE PELVIC RING INJURIES WITH AN INTERNAL ANTERIOR FIXATOR AND POSTERIOR FIXATION: INITIAL CLINICAL SERIES, VAIDYA, R., COLEN, R., VIGDORCHIK, J., TONNOS, F., AND SETHI, A. J. ORTHOP & TRAUMA: SURGERY 2012; 26:1-8. THIS ARTICLE OBJECTIVE IS TO PRESENT A NOVEL INTERNAL FIXATION DEVICE FOR STABILIZING UNSTABLE PELVIC FRACTURES USING SUPRA-ACETABULAR SPINAL PEDICLE SCREWS AND A SUBCUTANEOUS CONNECTING ROD (INFIX). THERE WERE 24 PATIENTS WITH AN AVERAGE AGE OF 40.3 YEARS (RANGE, 21-71YEARS) WITH ROTATIONAL OR VERTICALLY UNSTABLE PELVIC FRACTURES. IT IS UNCLEAR IF THE SYNTHES UNIVERSAL SPINE SYSTEM OR CLICK-X AND THE USE OF C-RINGS WERE ASSOCIATED WITH THE COMPLICATIONS AS THE ARTICLE FAILED TO IDENTIFY THE DEVICES ASSOCIATED WITH THE COMPLICATIONS. IN THE PRESENT CLINICAL SERIES, ALL FRACTURES HEALED WITHOUT SIGNIFICANT LOSS OF REDUCTION. THERE WERE NO INFECTIONS, DELAYED UNION OR NONUNION. MALE PATIENT (64 YRS.) REQUIRED REPOSITIONING OF THE PEDICLE SCREW AND (71 YRS.) MALE REQUIRED READJUSTMENT OF SCREW ROD JUNCTION. BOTH PATIENT TOLERATED THE PROCEDURE WELL AND WERE FAIRLY MOBILE AFTER THE PROCEDURE. TWO MALE PATIENTS DIED (42 YRS AND 44 YRS.) IN THE EARLY POSTOPERATIVE PERIOD SECONDARY TO MULTIPLE INJURIES AND MULTISYSTEM ORGAN FAILURE. THIS IS REPORT 4 OF 4 FOR (B)(4). THIS REPORT IS FOR READJUSTMENT OF UNKNOWN SCREW ROD JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377650 TRACTION, COMPONENT, INVASIVE JEC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention