BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 8271828 · Received January 23, 2019

    Report

    Report Number
    8030965-2019-60218
    Event Type
    Injury
    Date Received
    January 23, 2019
    Report Date
    January 3, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. - ATTACHMENT: (B)(6) REFID245.PDF.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: L. CAI ET AL (2018). COMPARISON OF THE TIGHT ROPE TECHNIQUE AND CLAVICULAR HOOK PLATE FOR THE TREATMENT OF ROCKWOOD TYPE III ACROMIOCLAVICULAR JOINT DISLOCATION. JOURNAL OF INVESTIGATIVE SURGERY 31. PAGE 226-233. (CHINA) THE AIM OF THIS STUDY WAS TO COMPARE THE CLINICAL OUTCOMES OF THE TIGHT ROPE SYSTEM AND CLAVICULAR HOOK PLATE FOR ROCKWOOD TYPE III ACROMIOCLAVICULAR JOINT DISLOCATION IN ADULTS. BETWEEN (B)(6) 2014, 69 PATIENTS, WITH ACUTE TYPE III AC JOINT DISLOCATION WERE ENTERED INTO THIS TRIAL. PATIENTS WERE RANDOMLY DIVIDED INTO TWO GROUPS FOR SURGICAL TREATMENT WITH THE SMALL INCISION TIGHTROPE TECHNIQUE (GROUP A) AND CLAVICULAR HOOK PLATE (GROUP B). AVERAGE AGE FOR PATIENTS IN GROUP A WITH 30 PATIENTS (19 MALE, 11 FEMALE) WAS 42.80 YEARS (RANGE, 19-68 YEARS) AND IN GROUP B WITH 39 PATIENTS (26 MALE, 13 FEMALE) WAS 41.79 YEARS (RANGE, 20-70 YEARS). CONSTANT-MURLEY SCORE (CS) AND VISUAL ANALOGUE SCALE SCORES WERE USED TO EVALUATE PATIENTS PREOPERATIVELY AND POSTOPERATIVELY. COMPLICATIONS WERE REPORTED AS FOLLOWS: 3 HAD SUPERFICIAL WOUND INFECTION WHICH WAS RESOLVED WITH ORAL ANTIBIOTICS AND DAILY DRESSING. 1 HAD NERVE PALSY WHICH WAS RESOLVED SPONTANEOUSLY WITHOUT TREATMENT. 1 PATIENT UNDERWENT SECONDARY SURGERY DUE TO A FALL AFTER SURGERY, CAUSING PLATE BREAKAGE. 3 REPORTED PATIENT DEATHS THAT WAS LOST TO FOLLOW-UP FOR UNKNOWN REASONS AS SEEN IN FIGURE 1. THIS REPORT IS FOR UNKNOWN CLAVICULAR HOOK PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE (1) UNKNOWN PLATE. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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: L. CAI ET AL (2018). "COMPARISON OF THE TIGHT ROPE TECHNIQUE AND CLAVICULAR HOOK PLATE FOR THE TREATMENT OF ROCKWOOD TYPE III ACROMIOCLAVICULAR JOINT DISLOCATION." JOURNAL OF INVESTIGATIVE SURGERY 31. PAGE 226-233 (CHINA). THE AIM OF THIS STUDY WAS TO COMPARE THE CLINICAL OUTCOMES OF THE TIGHT ROPE SYSTEM AND CLAVICULAR HOOK PLATE FOR ROCKWOOD TYPE III ACROMIOCLAVICULAR JOINT DISLOCATION IN ADULTS. BETWEEN JANUARY 2012 TO DECEMBER 2014, 69 PATIENTS, WITH ACUTE TYPE III AC JOINT DISLOCATION WERE ENTERED INTO THIS TRIAL. PATIENTS WERE RANDOMLY DIVIDED INTO TWO GROUPS FOR SURGICAL TREATMENT WITH THE SMALL INCISION TIGHTROPE TECHNIQUE (GROUP A) AND CLAVICULAR HOOK PLATE (GROUP B). AVERAGE AGE FOR PATIENTS IN GROUP A WITH 30 PATIENTS (19 MALE, 11 FEMALE) WAS 42.80 YEARS (RANGE, 19-68 YEARS) AND IN GROUP B WITH 39 PATIENTS (26 MALE, 13 FEMALE) WAS 41.79 YEARS (RANGE, 20-70 YEARS). CONSTANT-MURLEY SCORE (CS) AND VISUAL ANALOGUE SCALE SCORES WERE USED TO EVALUATE PATIENTS PREOPERATIVELY AND POSTOPERATIVELY. COMPLICATIONS WERE REPORTED AS FOLLOWS: 3 HAD SUPERFICIAL WOUND INFECTION WHICH WAS RESOLVED WITH ORAL ANTIBIOTICS AND DAILY DRESSING. 1 HAD NERVE PALSY WHICH WAS RESOLVED SPONTANEOUSLY WITHOUT TREATMENT. 1 PATIENT UNDERWENT SECONDARY SURGERY DUE TO A FALL AFTER SURGERY, CAUSING PLATE BREAKAGE. THIS REPORT IS FOR UNKNOWN CLAVICULAR HOOK PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63323 PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention