BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6814112 · Received August 23, 2017

    Report

    Report Number
    2520274-2017-12156
    Event Type
    Injury
    Date Received
    August 23, 2017
    Report Date
    August 15, 2017
    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

    BI, C; ET AL (2016) TREATMENT OF UNSTABLE POSTERIOR PELVIC RING FRACTURE WITH PEDICLE SCREW-ROD FIXATOR VERSUS LOCKING COMPRESSION PLATE: A COMPARATIVE STUDY. MEDICAL SCIENCE MONITOR 22:3764-3770. THIS REPORT IS FOR AN UNKNOWN 4.5MM LOCKING COMPRESSION PLATE (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: BI, C; ET AL (2016) TREATMENT OF UNSTABLE POSTERIOR PELVIC RING FRACTURE WITH PEDICLE SCREW-ROD FIXATOR VERSUS LOCKING COMPRESSION PLATE: A COMPARATIVE STUDY. MEDICAL SCIENCE MONITOR 22:3764-3770. THIS IS A RETROSPECTIVE STUDY TO ASSESS THE CLINICAL RESULTS OF TREATMENT FOR UNSTABLE POSTERIOR PELVIC FRACTURES USING A PEDICLE SCREW-ROD FIXATOR COMPARED TO USE OF A LOCKING COMPRESSION PLATE FROM (B)(6) 2010 TO (B)(6) 2014. OF THE 46 PATIENTS, (STUDY GROUP, 24 PATIENTS WITH PEDICLE SCREW ROD FIXATOR) AND (CONTROL GROUP, 22 PATIENTS WITH 4.5MM LOCKING COMPRESSION PLATE (LCP) WITH 10-11 HOLES (SYNTHES CO., (B)(4)). AMONG THEM, 31 PATIENTS (17 IN STUDY GROUP AND 14 IN CONTROL GROUP) WERE POLY-TRAUMATIZED. IN THE CONTROL GROUP, MALUNION OF A PUBIC RAMI FRACTURE WAS OBSERVED IN 1 PATIENT, AND INCISION INFECTIONS WERE OBSERVED IN 2 PATIENTS; HOWEVER, AFTER USING ANTIBIOTICS, THE SYMPTOMS OF INFECTION IN THESE 2 PATIENTS WERE CONTROLLED. IN THE CONTROL GROUP, THE MAJEED FUNCTIONAL EVALUATION SCORES RANGED FROM 60 TO 92 POINTS), WITH THE RESULT BEING RATED AS EXCELLENT IN 10 PATIENTS, GOOD IN 8, AND FAIR IN 4, WITH AN EXCELLENCE RATE OF 81.8%. IN 3 PATIENTS EVALUATED AS FAIR, WE FOUND SHORTENED LOWER EXTREMITY AND LIMP IN 1 PATIENT AND OBVIOUS PAIN OF THE SACROILIAC JOINT IN 2 PATIENTS. THIS IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A UNKNOWN 4.5MM LOCKING COMPRESSION PLATE AND REFERS TO THE SERIOUS INJURY 1 UNKNOWN PATIENT WHO EXPERIENCED SHORTENED LOWER EXTREMITY AND LIMP, AND 2 HAD PAIN OF THE SACROILIAC JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594404 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention