BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5018375 · Received August 20, 2015

    Report

    Report Number
    2520274-2015-15310
    Event Type
    Injury
    Date Received
    August 20, 2015
    Report Date
    August 17, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. : IHN, J, ET, AL (2008) ANTERIOR PLATING AND PERCUTANEOUS ILIOSACRAL SCREWING IN AN UNSTABLE PELVIC RING INJURY, J OP ORTHOP SCI, 13:107-115 THIS REPORT IS FOR AN UNKNOWN PLATE (UNKNOWN QUANTITY/UNKNOWN LOT). 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. 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: O,H; KIM, P; KIM, J; MIN, W; KYUUNG, H; ETAL (2008) ANTERIOR PLATING AND PERCUTANEOUS ILIOSACRAL SCREWING IN AN UNSTABLE PELVIC RING INJURY, J OPRTHOP SCI, 13:107-115. IN THIS RETROSPECTIVE STUDY, THE EFFECTIVENESS OF ANTERIOR PLATING WITH SUBSEQUENT PERCUTANEOUS ILIOSACRAL SCREWING FOR THE MANAGEMENT OF UNSTABLE PELVIC RING INJURIES IN 81 PATIENTS WERE EVALUATED. TWENTY-THREE OF THESE WERE TREATED WITH ANTERIOR PLATING AND A PERCUTANEOUS ILIOSACRAL SCREW FIXATION. OF THESE, 19 PATIENTS WERE FOLLOWED UP FOR 1 YEAR (8 MEN AND 11 WOMEN) FROM 1999 TO 2005. THE ANTERIOR RING WITH A SINGLE PELVIC RECONSTRUCTION PLATE (3.5 MM, SYNTHES, (B)(4)) WAS USED, UNLESS THE FRACTURES WERE LOCATED AROUND THE SYMPHYSIS PUBIS OR WERE NOT SEVERE ENOUGH TO HAVE THREE SCREWS IN EACH SEGMENT. REGARDING COMPLICATIONS, THERE WAS ONE DEEP INFECTION ON THE ANTERIOR FIXATION AREA. AFTER REMOVING THE ANTERIOR PLATE AND DEBRIDEMENT, THIS HEALED WITHOUT FURTHER DISPLACEMENT OF THE FRACTURES. METAL FAILURES OCCURRED IN 4 PATIENTS, ONE WITH TYPE-B AND THREE WITH TYPE-C FRACTURES. TWO FAILURES OCCURRED IN THE ANTERIOR PLATE, ONE WAS A PLATE BREAKAGE WITH NONUNION, SINCE IT WAS ASYMPTOMATIC, NO FURTHER PROCEDURE WAS CARRIED OUT; AND ONE WAS THE LOOSENING OF SCREWS.TWO OF THESE HAD PAIN DUE TO S1-S3 NERVE INJURIES, DYSTHESIA, AND A LIMITATION OF MOTION, AND THE OTHER ONE HAD MILD RESIDUAL SENSORY SYMPTOMS ONLY. ONE PATIENT HAD AN ANTERIOR SCREW BREAKAGE. THIS REPORT IS 1 OF 3 FOR (B)(4). PATIENT 14, (B)(6) FEMALE, EXPERIENCED A SERIOUS INJURY DEEP INFECTION, DEBRIDEMENT, PLATE REMOVAL/ REVISION (SI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551855 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention