BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: RECONSTRUCTION

    MDR report key: 8887374 · Received August 13, 2019

    Report

    Report Number
    2939274-2019-59746
    Event Type
    Injury
    Date Received
    August 13, 2019
    Report Date
    July 22, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A TOTAL OF 23 PATIENTS (18 MALES AND 5 FEMALES) WITH A MEAN AGE OF 35.3 YEARS (RANGE 17-63) WERE INCLUDED IN THIS STUDY. THIS REPORT IS FOR AN UNKNOWN 3.5 MM RECONSTRUCTION PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ROUTT, M.L. ET. AL. (1996), INTERNAL FIXATION IN PELVIC FRACTURES AND PRIMARY REPAIRS OF ASSOCIATED GENITOURINARY DISRUPTIONS: A TEAM APPROACH, THE JOURNAL OF TRAUMA: INJURY, INFECTION, AND CRITICAL CARE, VOL. 40 (5), PAGES 784-790 (USA). 10.1097/00005373-199605000-00018. THIS STUDY DESCRIBES A TREATMENT PROTOCOL AND REPORTS THE EARLY RESULTS OF 23 PATIENTS WITH UNSTABLE PELVIC FRACTURES AND ASSOCIATED BLADDER OR URETHRAL DISRUPTIONS, OR BOTH, TREATED SURGICALLY WITH OPEN REDUCTION AND INTERNAL FIXATION OF THE ANTERIOR PELVIC RING INJURIES AT THE SAME ANESTHETIC AND USING THE SAME SURGICAL EXPOSURE AS THE URETHRAL REALIGNMENTS OR BLADDER REPAIRS, OR BOTH. A TOTAL OF 23 PATIENTS (18 MALES AND 5 FEMALES) WITH A MEAN AGE OF 35.3 YEARS (RANGE 17-63) WERE INCLUDED IN THIS STUDY. 17 PATIENTS HAD ANTERIOR PELVIC STABILIZATIONS, AFTER OPEN REDUCTIONS, USING SINGLE 3.5-MM RECONSTRUCTION PLATES (SYNTHES, INC., PAOLI, PA.) OF VARIABLE LENGTHS DEPENDENT UPON THE INJURY PATTERNS. 5 PATIENTS HAD 2-HOLE 4.5-MM NARROW DYNAMIC COMPRESSION PLATES (SYNTHES, INC., PAOLI, PA) USED FOR SYMPHYSEAL FIXATION. FOLLOW-UP EXAMINATIONS WERE AVAILABLE FOR ALL THE PATIENTS AND RANGED FROM 3 TO 36 MONTHS WITH A MEAN OF 15.5 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 MALE PATIENT WAS A CHRONIC ALCOHOLIC AND HAD A CRUSH INJURY CAUSING BILATERAL PUBIC RAMI FRACTURES AND A DISPLACED SACRAL FRACTURE. THE PATIENT EXPERIENCED DELERIUM TREMENS THE NIGHT AFTER SURGERY AND WAS FOUND BY THE NURSING STAFF TO BE CONFUSED AND AMBULATING IN THE HALLWAYS WITHOUT ASSISTANCE. PELVIC RADIOGRAPHS DEMONSTRATED THE FAILURE OF FIXATION. THIS PATIENT UNDERWENT REPEAT OPEN REDUCTION AND INTERNAL FIXATION AFTER THE FAILURE WAS DIAGNOSED. ADDITIONAL DEVICES FOR THIS ARTICLE ARE CAPTURED ON RELATED COMPLAINTS (B)(4). THIS REPORT IS FOR AN UNKNOWN 3.5 MM RECONSTRUCTION PLATE. THIS IS REPORT 7 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684679 UNK - PLATES: RECONSTRUCTION PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention