BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP CLAVICLE HOOK PL 5H 15MM HOOK DEPTH/59MM/LT-STER

    MDR report key: 6871128 · Received September 15, 2017

    Report

    Report Number
    1719045-2017-10928
    Event Type
    Injury
    Date Received
    September 15, 2017
    Report Date
    August 24, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K061753
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 22-AUG-2014. EXPIRATION DATE: 31-JUL-2023 PART #: 241.085S, LOT#: 7764060 (STERILE) - 3.5MM LCP CLAVICLE HOOK PL 5H 15MM HOOK. DEPTH/59MM/LT-STER. QTY: 12. COMPONENT PART 241.085, 3.5MM LCP (TM) CLAVICLE HOOK PL, LOT 8991391. RAW MATERIAL RECEIVED FROM SYNTHES (B)(4). MOVED TO BP%% BLANK STORAGE ON 05-JUN-2014. 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. SCN NO: 10530 (STERIGENICS, CORONA), ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT HARDWARE REMOVAL OF A CLAVICLE HOOK PLATE ON (B)(6) 2017. THE PATIENT FELL ON HER SHOULDER AND WAS HAVING PAIN. THE SURGEON WAS GOING TO REMOVE THE PLATE AND REVISE DUE TO THE PAIN, BUT WHEN HE EXAMINED, IT WAS DISCOVERED THAT THE CLAVICLE WAS STABLE AND NO FURTHER DAMAGE. THE PLATE AND SCREWS WERE REMOVED WITH NO REVISION. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO REPORT OF PATIENT HARM OR SURGICAL DELAY. THERE ARE 5 DEVICES IN THIS COMPLAINT. THIS REPORT IS 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648251 3.5MM LCP CLAVICLE HOOK PL 5H 15MM HOOK DEPTH/59MM/LT-STER PLATE, FIXATION, BONE HRS SYNTHES MONUMENT 7764060

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention