BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: LOCKING

    MDR report key: 12664654 · Received October 20, 2021

    Report

    Report Number
    8030965-2021-08806
    Event Type
    Injury
    Date Received
    October 20, 2021
    Report Date
    September 22, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SHEN, G. ET AL (2021), COMPARISON OF THE TIGHTROPE SYSTEM VERSUS HOOK PLATE IN ACUTE ACROMIOCLAVICULAR JOINT DISLOCATIONS: A RETROSPECTIVE ANALYSIS, SCIENTIFIC REPORTS, VOL. 11 (11397), PAGES 1-7 (CHINA). THE AIM OF THIS RETROSPECTIVE NONRANDOMIZED CONTROL STUDY IS TO COMPARE THE CLINICAL AND RADIOLOGICAL RESULTS OF A MINIMALLY INVASIVE CORACOCLAVICULAR (CC) FIXATION WITH A SINGLE TIGHTROPE (MITR) TECHNIQUE AND THE HOOK PLATE (HP) TECHNIQUE FOR ACUTE ACROMIOCLAVICULAR (AC) JOINT DISLOCATION TREATMENT. BETWEEN JULY 2016 TO OCTOBER 2018, A TOTAL OF 16 PATIENTS (11 MALE AND 5 FEMALE) WITH A MEAN AGE OF 44.9 ± 11 YEARS WERE TREATED WITH THE MITR PROCEDURE AND 19 PATIENTS (10 MALE AND 9 FEMALE) WITH A MEAN AGE OF 40.2 ± 8.7 YEARS WERE TREATED USING THE HP PROCEDURE. THE HP PROCEDURE WAS PERFORMED USING A PREBENT PLATE (3.5 MM, TITAN, DEPUY SYNTHES, SWITZERLAND). THE MEAN FOLLOW-UP WAS 27 MONTHS (RANGE 15¿42 MONTHS) AND 30 MONTHS (RANGE 16¿40 MONTHS) IN THE MITR GROUP AND HP GROUP, RESPECTIVELY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD ACROMIAL OSTEOLYSIS. THIS REPORT IS FOR AN UNKNOWN SYNTHES LOCKING SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561677 UNK - SCREWS: LOCKING SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention