BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6537082 · Received May 2, 2017

    Report

    Report Number
    2520274-2017-11564
    Event Type
    Injury
    Date Received
    May 2, 2017
    Report Date
    April 5, 2017
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PARK, K.S., CHAN, C.K., LEE, G.W., AHN, H.W., AND YOON, T.R. (2017) OUTCOME OF ALTERNATIVE APPROACH TO DISPLACED ACETABULAR FRACTURES. INJURY, INT. J. CARE INJURED 48(2017)388-393. (B)(6). THIS IS FOR UNKNOWN PLATE/UNKNOWN PART NUMBER/UNKNOWN LOT/UNKNOWN QUANTITY. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. 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. (B)(4) . 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

    LITERATURE ARTICLE RECEIVED. THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: PARK, K.S., CHAN, C.K., LEE, G.W., AHN, H.W., AND YOON, T.R. (2017) OUTCOME OF ALTERNATIVE APPROACH TO DISPLACED ACETABULAR FRACTURES. INJURY, INT. J. CARE INJURED 48(2017)388-393. SOUTH KOREA A RETROSPECTIVE STUDY WAS CARRIED OUT WITH 23 PATIENTS (17 MALES, 6 FEMALES) WITH AN AVERAGE AGE OF 50.1 YEARS (RANGE, 36-68 YEARS) WITH DISPLACED ACETABULAR FRACTURE TREATED WITH COMBINED INCISION AND PLATE-CABLE SYSTEMS. THE MEAN BODY MASS INDEX WAS 21.3 (RANGE, 15.8-27.7). A CURVED RECONSTRUCTION PLATE (SYNTHES, (B)(6)) AND SCREWS WERE USED AFTER THE CABLE REDUCTION. THERE WERE 12 ANATOMICAL, 6 IMPERFECT, AND 5 POOR REDUCTIONS. COMPLICATIONS DOCUMENTED: COMPLICATIONS DOCUMENTED: THREE LATERAL FEMORAL CUTANEOUS NERVE INJURIES, TWO CONVERSION TO TOTAL HIP ARTHROPLASTY DUE TO NONUNION OF THE FEMORAL NECK FRACTURE, THREE BROKER STAGE 1 HETEROTROPHIC OSSIFICATION, AND ONE PULMONARY EMBOLISM. ONE PATIENT EXPERIENCED OSTEOARTHRITIS WITH POOR REDUCTION. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNTHES RECONSTRUCTION PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317767 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention