BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIRE, SURGICAL

    MDR report key: 6520370 · Received April 25, 2017

    Report

    Report Number
    2520274-2017-11512
    Event Type
    Injury
    Date Received
    April 25, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. IS THERE A CLINICAL BENEFIT OF ADDITIONAL TENSION BAND WIRING IN PLATE FIXATION OF THE SYMPHYSIS? THIS REPORT IS FOR AN UNKNOWN CERCLAGE WIRES (UNKNOWN QUANTITY/UNKNOWN LOT). (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. (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 LITERATURE ARTICLE: PARK, M; YOON, S; CHOI, S; LEE, K (2017) IS THERE A CLINICAL BENEFIT OF ADDITIONAL TENSION BAND WIRING IN PLATE FIXATION OF THE SYMPHYSIS? BMC MUSCULOSKEL DISORDERS, 18:40, 1-6. THE PURPOSE OF THIS STUDY WAS TO DETERMINE WHETHER ADDITIONAL TENSION BAND WIRING IN THE PLATE FOR TRAUMATIC DISRUPTION OF SYMPHYSIS PUBIS HAS CLINICAL BENEFITS. THEREFORE, OUTCOMES AND COMPLICATIONS WERE COMPARED BETWEEN A PLATE FIXATION GROUP AND A PLATE WITH TENSION BAND WIRING GROUP. BETWEEN MARCH 2009 AND MARCH 2013, 64 PATIENTS WITH PUBIC SYMPHYSIS RUPTURE UNDERWENT ORIF WITH A PLATE ALONE OR A PLATE WITH TENSION BAND WIRING. ALL THE PATIENTS WERE FOLLOWED UP FOR A MINIMUM OF 24 MONTHS (MEAN, 34.4 MONTHS; RANGE, 26¿39 MONTHS). OF THE PATIENTS, 54 WERE MALE AND 10 WERE FEMALE, WITH A MEAN AGE OF 42.7 YEARS (RANGE, 16¿74 YEARS). TO STUDY THE CONSEQUENCES OF THIS CHANGE, WE DIVIDED THE PATIENTS INTO 2 GROUPS, THE PLATE FIXATION GROUP AND THE PLATE FIXATION WITH TENSION BAND WIRING GROUP. DURING THE STUDY, 39 PATIENTS UNDERWENT PLATE FIXATION ONLY, AND 25 PATIENTS UNDERWENT SYMPHYSIS PUBIS PLATING WITH TENSION BAND WIRING. TWO FIGURE-OF-8 TENSION BAND CERCLAGE WIRES (1.25 MM IN DIAMETER; SYNTHES) WERE AUGMENTED OVER THE PLATE THROUGH DRILLING HOLES FOR WIRES ON THE PUBIC BODY AFTER THE PLATE FIXATION. THE ADDITIONAL TENSION-BAND WIRING PROCEDURE GENERALLY TOOK 10 MIN. IN THE PLATE FIXATION GROUP, POSTOPERATIVE COMPLICATIONS INCLUDED FIXATION FAILURE IN 4 PATIENTS (10.3%), OF WHOM 3 (7.7%) UNDERWENT REVISION SURGERY. ONE PATIENT WITH FIXATION FAILURE DID NOT REQUIRE FURTHER SURGERY BECAUSE OF A RELATIVELY GOOD FUNCTIONAL OUTCOME DESPITE THE LOSS OF FIXATION. IN THE PLATE WITH TENSION BAND WIRING GROUP, NO EARLY POSTOPERATIVE COMPLICATION OCCURRED. WIDENING OF THE SYMPHYSEAL WIDTH (=10 MM) WAS OBSERVED ON THE POSTOPERATIVE RADIOGRAPHS OF 12 PATIENTS (30.7%), AND THE DIFFERENCE FROM THAT ON THE PREOPERATIVE RADIOGRAPH WAS SIGNIFICANT. DURING THE FOLLOW-UP PERIOD, ONE PATIENT (4%) HAD RECURRENT WIDENING OF THE PUBIC SYMPHYSIS AT THE FIRST POSTOPERATIVE VISIT BUT DID NOT REQUIRE FURTHER SURGICAL PROCEDURE BECAUSE THE FUNCTIONAL OUTCOME WAS GOOD. THERE WAS 1 REVISION IN THE PLATE GROUP WITH TENSION BAND WIRING. IN THE ALL-CAUSE OVERALL RATE OF REVISION SURGERY, INCLUDING HARDWARE REMOVAL BY ANY REASON DURING FOLLOW-UP, THE PLATE WITH TENSION BAND WIRING GROUP SHOWED A SIGNIFICANTLY LOWER FREQUENCY. THIS IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN CERCLAGE WIRES AND REFERS TO THE SERIOUS INJURY OF 1 UNKNOWN PATIENT WHO EXPERIENCED SYMPHYSEAL WIDTH WIDENING AND 1 PATIENT WHO HAD A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300498 WIRE, SURGICAL LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention