BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP CLAVICLE HOOK PL 6H 18MM HOOK DEPTH/73MM/RT-STER

    MDR report key: 5095216 · Received September 22, 2015

    Report

    Report Number
    2520274-2015-16065
    Event Type
    Injury
    Date Received
    September 22, 2015
    Report Date
    September 10, 2015
    Manufacturer
    SYNTHES RARON
    Product Code
    HRS
    PMA / PMN Number
    PK061753
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION WAS NOT PROVIDED BY REPORTER. THIS REPORT IS FOR ONE UNKNOWN CLAVICLE HOOK PLATE. PART AND LOT NUMBERS WERE NOT PROVIDED BY REPORTER. DATE OF EXPLANT IS UNKNOWN BUT MAY BE (B)(6) 2015. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IT WAS REPORTED THAT THE SUBJECT DEVICE HAS BEEN DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR EVALUATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DHR REVIEW ¿ 241.096S ¿ 8812134: MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 03.MAR.2014. EXPIRY DATE: 01.FEB.2024. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE AN UNKNOWN CLAVICLE HOOK PLATE DUE TO PAIN AND POSSIBLE METALLOSIS. DURING THE SURGERY, IT WAS NOTED THAT THE SOFT TISSUE AROUND THE PLATE WAS BLACK. SAMPLES OF THE TISSUE WERE SENT TO THE LAB FOR TESTING. THIS REPORT IS FOR ONE UNKNOWN CLAVICLE HOOK PLATE. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: AT THE TIME OF IMPLANTATION, THE SURGEON HAD INTENDED TO REMOVE THE PLATE 3 MONTHS AFTER IMPLANTATION. WHEN THE PLATE WAS REMOVED ON (B)(6) 2015, IT WAS NOT REPLACED WITH A NEW IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626746 3.5MM LCP CLAVICLE HOOK PL 6H 18MM HOOK DEPTH/73MM/RT-STER PLATE, FIXATION, BONE HRS SYNTHES RARON 8812134

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention