BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3813213 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11237
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. YI, J. W., OH, J.-K., HAN, S.-B., SHIN, S.-J., OH, C.-W., & Y., Y.-C. (2013). HEALING PROCESS AFTER RIGID PLATE FIXATION OF HUMERAL SHAFT FRACTURES REVISITED. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 133(6), 811-817. THIS REPORT IS FOR AN UNKNOWN SCREW. 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. 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. YI, J. W., OH, J.-K., HAN, S.-B., SHIN, S.-J., OH, C.-W., & Y., Y.-C. (2013). HEALING PROCESS AFTER RIGID PLATE FIXATION OF HUMERAL SHAFT FRACTURES REVISITED. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 133(6), 811-817. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE RADIOLOGICAL HEALING PROCESS AFTER OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF HUMERAL SHAFT FRACTURES WITH PLATE. FROM MARCH 2002 THROUGH NOVEMBER 2077, DATA FROM 53 CONSECUTIVE PATIENTS WERE REVIEWED WHO HAD UNDERGONE RIGID PLATE FIXATION OF OTA 12 A OR B HUMERAL SHAFT FRACTURE. THE MEAN AGE OF THE PATIENTS AT THE TIME OF SURGERY WAS 39.4 (RANGE 16-82). LC-DCP (LIMITED CONTACT-DYNAMIC COMPRESSION PLATE) WAS SELECTED WITH ALL STUDY SUBJECTS. QUALITY OF REDUCTION AND HEALING PROCESS WAS ANALYZED ON RADIOGRAPHS. CLINICAL SYMPTOM AND DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) SCORES WERE RECORDED AT FOLLOW-UP VISITS. THERE WERE 28 COMPRESSION AND 25 NEUTRALIZATION PLATINGS. THE MEAN GAP SIZE ON THE POSTOPERATIVE RADIOGRAPH WAS 1.4 (RANGE 0.1-6.1). 50 CASES (94.3 %) HEALED, WHILE THREE CASES ENDED UP WITH NON-UNION. 28 (52.8 %) CASES SHOWED PRIMARY HEALING AND 22 CASES (41.5 %) SHOWED SECONDARY HEALING WITH CALLUS BRIDGING. AMONG THE CASES WITH SECONDARY HEALING, CALLUS FORMATION WITH RESORPTION WAS IDENTIFIED IN 13 CASES. THE TYPE OF FRACTURE, MODE OF COMPRESSION AND SIZE OF GAP ON RADIOGRAPHS AFTER RIGID PLATE FIXATION WERE FOUND TO BE STATISTICALLY SIGNIFICANT FACTORS FOR HEALING TYPE (P = 0.026, 0.002, AND <0.001, RESPECTIVELY). THREE CASES WITH NON-UNION SHOWED NO IMPROVEMENT IN DASH SCORES. ONE OF THE PATIENTS THAT EXPERIENCED NON-UNION WAS A (B)(6) MAN WHO FELL DOWN A FLIGHT OF STAIRS. TWO WEEKS AFTER OPERATION THERE WAS A LOSS OF REDUCTION WITH IMPLANT LOOSENING. AT A YEAR, NON-UNION WAS IDENTIFIED. BOTH PRIMARY AND SECONDARY HEALING PROCESSES WERE OBSERVED AFTER RIGID PLATE FIXATION OF OTA 12 A OR B HUMERAL SHAFT FRACTURES. OUR STUDY REVEALED THAT SIZE OF GAP, MODE OF COMPRESSION, TYPE OF FRACTURE COULD AFFECT THE TYPE OF HEALING, AND THAT PERIOSTEAL CALLUS FORMATION CAN OCCUR AFTER RIGID PLATE FIXATION. THIS REPORT IS FOR 1 DEVICE. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. TWO OF 4 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291313 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention