BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2014-00909

    MDR report key: 3651735 · Received February 27, 2014

    Report

    Report Number
    2520274-2014-00909
    Event Type
    Injury
    Date Received
    February 27, 2014
    Report Date
    January 31, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ARTICLE: MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR HUMERAL SHAFT FRACTURES: ARE RESULTS REPRODUCIBLE? CONCHA,J.A.,SANDOVAL,A AND STREUBEL,P.N.; INTERNATIONAL ORTHOPAEDICS (SICOT) (2010) 34:1297-1305. DATE OF EVENT: INTERNATIONAL ORTHOPAEDICS (SICOT) (2010) 34:1297-1305. ADDITIONAL DEVICE INFO: DEVICE IS AN UNKNOWN PLATE, QUANTITY 1. PMA/510(K): CANNOT BE DETERMINED WITHOUT A PART NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR HUMERAL SHAFT FRACTURES: ARE RESULTS REPRODUCIBLE. MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) HAS BEEN ADVOCATED AS A SAFE APPROACH TO HUMERAL SHAFT FRACTURE MANAGEMENT. WE EVALUATED THE REPRODUCIBILITY OF THIS TECHNIQUE IN A REGIONAL HOSPITAL. BETWEEN (B)(6) 2004 AND (B)(6) 2007, 35 PATIENTS WITH A FRACTURE OF THE HUMERAL DIAPHYSIS WERE TREATED USING MIPO TECHNIQUE. FIFTEEN PATIENTS HAD AN OPEN FRACTURE, SIX A PREOPERATIVE RADIAL NERVE PALSY, AND NINE A CONCOMITANT THORACIC, MUSCULOSKELETAL OR VASCULAR INJURY. MEAN AGE OF THE 26 MALES AND NINE FEMALES WAS 33 YEARS (RANGE, 19¿54). THE PURPOSE OF THIS STUDY WAS TO ESTABLISH THE REPRODUCIBILITY OF MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) OF HUMERAL SHAFT FRACTURES. BASED ON AVAILABILITY, FRACTURE FIXATION WAS PERFORMED IN 26 PATIENTS USING A 4.5-MM DYNAMIC COMPRESSION PLATE (DCP) AND IN NINE PATIENTS USING A 4.5-MM LOCKING COMPRESSION PLATE (LCP) (B)(4). OUR STUDY SUPPORTS MIPO AS A SAFE AND EFFICIENT PROCEDURE FOR HUMERAL SHAFT FRACTURE TREATMENT. ADEQUATE HEALING AND LOW INFECTION RATES CAN BE OBTAINED. RISK OF IATROGENIC RADIAL NERVE INJURY IS LOW IF THE APPROPRIATE SURGICAL TECHNIQUE IS USED. FURTHERMORE, FRACTURES ACCOMPANIED BY RADIAL NERVE INJURIES MAY BE ADEQUATELY FIXED USING THIS APPROACH. THE HIGH RATES OF POSTOPERATIVE ANGULATION FOUND IN OUR STUDY REFLECT THE FACT THAT MIPO IS A DEMANDING SURGICAL TECHNIQUE THAT REQUIRES ADEQUATE IMAGING AND SURGICAL EXPERIENCE. ELBOW FLEXION CONTRACTURE SHOULD ALSO BE REGARDED AS A POSSIBLE COMPLICATION USING THIS APPROACH AND MAY INDICATE THE NEED FOR A FORMAL ELBOW REHABILITATION PROTOCOL. THREE NON-UNIONS OCCURRED, WHICH HEALED AFTER REVISION WITH HARDWARE EXCHANGE USING STANDARD OPEN REDUCTION AND INTERNAL FIXATION WITH AUTOGENOUS ILIAC CREST BONE GRAFTING. ONE SUPERFICIAL INFECTION OCCURRED WHICH RESOLVED WITH ANTIBIOTIC TREATMENT. ONE PATIENT DEVELOPED A DEEP INFECTION THAT RESPONDED TO SERIAL DEBRIDEMENT AND IRRIGATION WITH CULTURE SPECIFIC ANTIBIOTICS. REMOVAL OF HARDWARE WAS NOT DEEMED NECESSARY AS NO SIGNS OF LOOSENING WERE PRESENT AND PROGRESSIVE BONE HEALING WAS VISIBLE ON RADIOGRAPHS. ONE FRACTURE WAS DEFINED AS A MALUNION, WHICH HEALED WITH 20 DEGREES OF VARUS ANGULATION. TWO PATIENTS HAD AN EXTENSION LAG OF 15 DEGREES, 20 DEGREES AND 30 DEGREES, RESPECTIVELY. IN NINE ELBOWS ROM (RANGE OF MOTION) WAS LESS THAN 100 DEGREES. SEVEN PATIENTS WITH ROM OF LESS THAN 100 DEGREES HAD AN EXTENSION LAG OF 20 DEGREES AND TWO OF 30 DEGREES. THIS REPORT IS FOR AN UNKNOWN 4.5MM DYNAMIC COMPRESSION PLATE (DCP) AND A 4.5MM LOCKING COMPRESSION PLATE (LCP). PATIENTS WERE IMPLANTED WITH EITHER DCP OR LCP. THERE WAS NO INFORMATION INDICATING WHICH DEVICE WAS ASSOCIATED WITH THE SPECIFIC REPORTED PATIENT EVENTS. THIS REPORT IS FOR SERIOUS INJURY IN TWO PATIENTS WHERE INFECTION OCCURRED. THIS REPORT IS 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122537 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention