BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 8709916 · Received June 18, 2019

    Report

    Report Number
    8030965-2019-65454
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    September 1, 2011
    Report Date
    May 22, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PLATES/UNKNOWN LOT NUMBER. WITHOUT THE SPECIFIC PART NUMBER, THE UDI NUMBER AND 510K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. INVESTIGATION SUMMARY - THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN. 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. (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KAMRAN, R. ET AL (2011), PIN AND PLATE FIXATION IN COMPLEX DISTAL HUMERUS FRACTURES: SURGICAL TECHNIQUE AND RESULTS, INTERNATIONAL ORTHOPAEDICS (SICOT) (2012) VOLUME 36, PAGES 839¿844 (IRAN) DOI 10.1007/S00264-011-1343-2. THIS STUDY AIMS TO PRESENT A NOVEL TECHNIQUE OF FIXATION FOR COMPLEX DISTAL HUMERUS FRACTURES AND TO EVALUATE THE FUNCTIONAL OUTCOME OF PATIENTS WITH THIS TYPE OF FIXATION. BETWEEN MAY 2007 AND MARCH 2009, A TOTAL OF 19 PATIENTS (10 MALE 9 FEMALE)WITH AN AVERAGE AGE OF 46 YEARS (RANGE 17¿73),WITH LOW DISTAL HUMERUS FRACTURE,COMMINUTED ARTICULAR SURFACE,FRACTURE OR FRACTURES WITH POOR BONE QUALITY AND WERE PRIMARILY TREATED USING PIN AND PLATE FIXATION WERE INCLUDED IN THE STUDY. FIXATION OF THE FRACTURE WAS ATTEMPTED USING A DISTAL HUMERUS LOCKING PLATE OR 3.5-MM RECONSTRUCTION PLATE. IF THE ENTIRE OR SOME PARTS OF THE FRACTURE COULD NOT BE STABILISED BY STANDARD TECHNIQUES K-WIRES AND CONTOURED THREE- OR FOUR-HOLE RECONSTRUCTION PLATE WERE USED. THE MEAN FOLLOW-UP WAS 12 MONTHS,WITH A RANGE OF FIVE TO 22 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: THE COMPLAINT INVOLVES 28 DEVICES. DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT WILL BE CAPTURED UNDER 4 SEPARATE COMPLAINTS AS LISTED BELOW: (B)(4). A CASE OF A (B)(6) YEAR OLD MALE HAD BRACHIAL PLEXUS INJURY AND PROXIMAL HUMERUS FRACTURE AND DID NOT ACHIEVED MAXIMAL STABILITY SCORE. A CASE OF A (B)(6) YEAR OLD FEMALE HAD SEVERE RHEUMATOID ARTHRITIS WITH MULTIPLE JOINT DEFORMITIES. A CASE OF A (B)(6) YEAR OLD FEMALE HAD ULNAR NERVE PALSY POSTOPERATIVELY, BUT SYMPTOMS DECREASED WITH TIME AND RESOLVED IN SIX MONTHS WITH NO OBJECTIVE EVIDENCE OF DEFICIT IN THE FOLLOW-UP EVALUATION AND COLLAPSE OF CAPITULUM. A CASE OF A (B)(6) YEAR OLD MALE HAD OLECRANON FIBROUS UNION OF THE OLECRANON WITH NO CLINICAL SYMPTOMS. A CASE OF A (B)(6) YEAR OLD FEMALE HAD CONGENITAL RADIAL HEAD DISLOCATION UNFAVOURABLE ARC OF MOTION OF 70°. 1 PATIENT HAD IMPLANT REMOVAL DUE TO COMPLAINT OF PROMINENT PIN AND SKIN IRRITATION. 1 SUPERFICIAL WOUND INFECTION THAT RESOLVED WITH ORAL ANTIBIOTICS. A CASE OF A (B)(6) YEAR OLD FEMALE DIED AFTER 5 MONTHS. THIS REPORT IS FOR AN UNKNOWN SYNTHES DISTAL HUMERUS LOCKING PLATE AND 3.5 MM RECONSTRUCTION PLATE. THIS IMPACTED PRODUCT CAPTURE A CASE OF A (B)(6) YEAR OLD MALE WHO HAD OLECRANON FIBROUS UNION OF THE OLECRANON WITH NO-CLINICAL SYMPTOMS. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500821 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention