BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8533109 · Received April 19, 2019

    Report

    Report Number
    8030965-2019-62980
    Event Type
    Injury
    Date Received
    April 19, 2019
    Report Date
    April 11, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN SCREWS. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR UNKNOWN SCREWS. 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: SMEJKAL, K., LOCHMAN, P., DEDEK, T. AND TRLICA, J. (2014), SURGICAL TREATMENT OF HUMERAL DIAPHYSEAL FRACTURES, ACTA CHIRUGIAE ORTHOPAEDICAE ET TRAUMATOLOGIAE CECHOSLOVACA, VOL. 81, PAGES 129-134 (CZECH REPUBLIC). THE AIM OF THE STUDY WAS TO COMPARE TWO SURGICAL METHODS OF TREATING DIAPHYSEAL FRACTURES OF THE HUMERUS. BETWEEN SEPTEMBER 2009 TO JANUARY 2013, 49 PATIENTS WERE INCLUDED IN THE STUDY. 2 PATIENTS DIED DURING THE STUDY AND 2 PATIENTS WERE LOST TO FOLLOW-UP. IN TOTAL, 45 PATIENTS (23 MALE AND 22 FEMALE) WITH A MEAN AGE OF 52 YEARS WERE EVALUATED. PATIENTS WERE DIVIDED INTO 2 GROUPS. THE FIRST GROUP INCLUDED PATIENTS WHO UNDERWENT MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) USING AN UNKNOWN SYNTHES ANGULARY STABLE LOCKING COMPRESSION PLATE. THE SECOND GROUP INCLUDED PATIENTS WHO UNDERWENT INTRAMEDULLARY OSTEOSYNTHESIS USING AN UNKNOWN SYNTHES EXPERT HUMERAL NAIL (EHN). THE FOLLOW-UP DURATION WAS 2 YEARS ON AVERAGE. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 PATIENTS DIED DURING THE STUDY. ONE OF THEM WAS A MAN WITH GENERALIZED CARCINOMA OF UNCLEAR ETIOLOGY AND ONE WOMAN. MIPO GROUP- 1 PATIENT HAD MALPOSITION WHEN HEALING. 2 PATIENTS, THE MOTION OF THE SHOULDER JOINT WAS IMPEDED BY THE PHILOS IMPLANT (ALSO ASSOCIATED WITH PROLONGED FRACTURE HEALING IN ONE CASE). 1 PATIENT HAD AN ALGODYSTROPHY SYNDROME DEVELOPED BUT THAT WAS DUE TO THE IPSILATERAL FRACTURE OF THE FOREARM. 1 PATIENT HAD NONUNION. 1 PATIENT HAD MALUNION. 1 PATIENT EXPERIENCED A FALSE JOINT WAS CREATED DUE TO THE INSUFFICIENT REDUCTION IN THE LONG OBLIQUE FRACTURE WHICH DEMANDED REPEATED SURGERY BY ORIF TECHNIQUE. EHN GROUP- 3 PATIENTS HAD A SUBACROMIAL IMPINGEMENT SYNDROME, WHICH WAS ONLY ASSOCIATED ONCE WITH THE NAIL PROMINENCE PROXIMALLY. THE CONDITION WAS RESOLVED BY EARLY REMOVAL OF THE OSTEOSYNTHETIC MATERIAL AFTER THE FRACTURE HEALED. 1 PATIENT HAD IATROGENIC RADIAL NERVE PALSY, WHICH WAS CAUSED BY NERVE DRAGGING DURING FRACTURE REDUCTION AND WHICH WAS MANAGED CONSERVATIVELY - BY REHABILITATION AND VITAMIN THERAPY. 1 PATIENT HAD A FALSE JOINT DEVELOPED THAT WAS CLINICALLY SILENT AND DID NOT REQUIRE SURGICAL INTERVENTION. THIS REPORT IS FOR AN UNKNOWN SYNTHES ANGULARY STABLE LOCKING COMPRESSION PLATE AND AN UNKNOWN SYNTHES EXPERT HUMERAL NAIL. 1 PATIENT HAD ONE OF THE PROXIMAL LOCKING SCREWS MIGRATED, WHICH WE SUBSEQUENTLY EXTRACTED. THIS REPORT IS FOR UNKNOWN SCREWS. IT CAPTURES MALPOSITIONING, PROLONGED FRACTURE HEALING, MOTION OF SHOULDER JOINT IMPEDED BY PHILOS IMPLANT, NONUNION, MALUNION, FALSE JOINT WAS CREATED. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325923 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention