BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6971085 · Received October 24, 2017

    Report

    Report Number
    2520274-2017-12517
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    March 20, 2017
    Report Date
    October 5, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. (B)(4). 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 · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: ERDLE, B; ET AL (2017) COMPARATIVE ANALYSIS OF LOCKING PLATE VERSUS HOOK PLATE OSTEOSYNTHESIS OF NEER TYPE IIB LATERAL CLAVICLE FRACTURES. ARCH ORTHOP TRAUMA SURG, 137:651-662. THIS RETROSPECTIVE, OBSERVATIONAL COHORT STUDY TO ANALYZE AND COMPARE CLINICAL AND RADIOLOGICAL RESULTS AND COMPLICATIONS OF LOCKING PLATE OSTEOSYNTHESIS (LPO) VERSUS HOOK PLATE OSTEOSYNTHESIS (HPO) WITH ACROMIOCLAVICULAR JOINT (ACJ) STABILIZATION. FOR LPO, EITHER A 3.5 MM LCP T-PLATE (DEPUY SYNTHES) DESIGNED FOR DISTAL RADIUS FRACTURES OR LCP SUPERIOR LATERAL CLAVICLE PLATE (DEPUY SYNTHES) WAS USED. FOR HPO, A 3.5 MM LCP CLAVICULAR HOOK PLATE (DEPUY SYNTHES, WEST CHESTER, USA) WAS USED. THERE WERE 32 PATIENTS (19 HPO, 13 LPO) WITH A MEAN AGE OF 44.1±14.2 YEARS AT SURGERY. THE MEAN FOLLOW-UP PERIOD WAS 54.2 MONTHS (RANGE 25.2¿111.4 MONTHS). HPO COMPLICATIONS INCLUDED 1 NON-UNION WITH NO REVISION, 2 DELAYED UNIONS, 1 PERI-IMPLANT FRACTURE WITH REVISION, 5 PERSISTENT ACROMIAL OSTEOLYSIS AND 8 POSTTRAUMATIC ACJ ARTHROSIS. LPO COMPLICATIONS INCLUDED 3 DELAYED UNIONS, 1 POST TRAUMATIC ACJ ARTHROSIS. HETEROTOPIC OSSIFICATIONS IN THE CORACOCLAVICULAR REGION WERE PRESENT IN 12 PATIENTS (37.5%) (N=9 HP, N=3 LP; P=0.21) AND DID NOT INFLUENCE FUNCTIONAL OUTCOME MEASURES. THIS IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LCP PLATE AND REFERS TO THE SERIOUS INJURY OF 1 UNKNOWN PATIENT WHO EXPERIENCED NON-UNION, 5 DELAYED UNIONS, 1 PERI-IMPLANT FRACTURE WITH REVISION, 5 PERSISTENT ACROMIAL OSTEOLYSIS, 9 POSTTRAUMATIC ACJ ARTHROSIS AND 12 HETEROTOPIC OSSIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753166 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention