BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8264283 · Received January 21, 2019

    Report

    Report Number
    8030965-2019-60113
    Event Type
    Injury
    Date Received
    January 21, 2019
    Report Date
    December 30, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. 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: JENSEN G, KATTHAGEN JC, ALVARADO LE, LILL H, VOIGT C ( 2014). HAS THE ARTHROSCOPICALLY ASSISTED REDUCTION OF ACUTE AC JOINT SEPARATIONS WITH THE DOUBLE TIGHT-ROPE TECHNIQUE ADVANTAGES OVER THE CLAVICULAR HOOK PLATE FIXATION?. KNEE SURGERY SPORTS TRAUMATOLOGY ARTHROSCOPY. VOLUME 22. PAGE 422-430. (GERMANY). THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO COMPARE RESULTS AFTER ARTHROSCOPICALLY ASSISTED 2-BUNDLE REDUCTION OF THE ACROMIOCLAVICULAR JOINT (DOUBLE TIGHTROPE TECHNIQUE, 2ND GENERATION) WITH RESULTS AFTER CLAVICULAR HOOK PLATE FIXATION IN ACUTE HIGH-GRADE ACROMIOCLAVICULAR JOINT SEPARATIONS TO GIVE FIRST EVIDENCE TO THE QUESTION WHETHER NEW ENDOBUTTON-FIXATION TECHNIQUES LEAD TO COMPARABLE OR EVEN BETTER RESULTS THAN THE PREVIOUSLY DESCRIBED OPEN ACROMIOCLAVICULAR JOINT REPAIR. BETWEEN 2004 AND 2010, 69 PATIENTS WITH ACUTE ACROMIOCLAVICULAR JOINT SEPARATIONS TYPE ROCKWOOD III AND V UNDERWENT TO SURGICAL RECONSTRUCTION. 32 PATIENTS OF THESE PATIENTS UNDERWENT A DOUBLE TIGHTROPE TECHNIQUE WHILE 37 PATIENTS WERE IMPLANTED WITH A CLAVICULAR HOOK PLATE, PREDOMINANTLY A 3.5MM UNKNOWN SYNTHES LOCKING COMPRESSION PLATE CLAVICULAR HOOK PLATE. OF THE PATIENTS IMPLANTED WITH THE HOOK PLATE, ONLY 30 PATIENTS (2 FEMALES AND 28 MALES, AVERAGE AGE OF 39 YEARS (RANGE, 18-68 YEARS) COULD BE EXAMINED. 2 PATIENTS WERE NOT AVAILABLE AND 5 PATIENTS REFUSED PARTICIPATION. DURING THE FIRST 6 WEEKS AFTER HOOK PLATE IMPLANTATION, MOTION WAS LIMITED TO 90 DEGREE FLEXION AND ABDUCTION. FROM THE 7TH WEEK ON, A FREE RANGE OF MOTION WAS ALLOWED. IMPLANT REMOVAL WAS PERFORMED 3 MONTHS AFTER SURGERY. CLINICAL ASSESSMENT INCLUDED A STRUCTURED INTERVIEW INCLUDING EVALUATION OF PATIENT¿S SATISFACTION, A 5-PART SATISFACTION SCALE (1: ¿¿EXCELLENT¿¿ TO 5: ¿¿POOR¿¿) FOR FUNCTIONAL AND COSMETIC RESULTS. MEDIAN FOLLOW-UP OF 48 MONTHS (RANGE, 7-77 MONTHS). COMPLICATIONS WERE REPORTED AS FOLLOWS: 19 PATIENTS HAD HYPERTROPHIC SCARS. 1 PATIENT HAD REVISION DUE TO POST-TRAUMATIC STIFFNESS. 2 PATIENTS HAD REVISION DUE TO STIFFNESS IN COMBINATION WITH SYMPTOMATIC ACROMIOCLAVICULAR JOINT OSTEOARTHRITIS. 1 PATIENT HAD REVISION DUE TO AN ACROMIAL FRACTURE. 6 PATIENTS HAD RADIOLOGICAL SIGNS OF OSTEOLYSIS. UNKNOWN PATIENTS HAD 4 CORACOCLAVICULAR LIGAMENT CALCIFICATIONS UPON SONOGRAPHIC EXAMINATION. UNKNOWN PATIENTS HAD DEGENERATIVE CHANGES UPON SONOGRAPHIC EXAMINATION. UNKNOWN PATIENTS HAD SLIGHT LOSS OF REDUCTION OF 2-4MM AT FOLLOW-UP. UNKNOWN PATIENTS HAD PARTIAL LOSS OF REDUCTION OF 4-8 MM AT FOLLOW-UP. UNKNOWN PATIENTS HAD DISLOCATION WITH LOSS OF REDUCTION OF MORE THAN 8MM AT FOLLOW-UP. UNKNOWN PATIENTS HAD POOR RESULTS OF CONSTANT SCORE. UNKNOWN PATIENTS HAD POOR RESULTS OF TAFT SCORE. THIS REPORT IS FOR TWO (2) DEVICES- AN UNKNOWN SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56125 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention