BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5384283 · Received January 21, 2016

    Report

    Report Number
    2520274-2016-10380
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Report Date
    January 7, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    PK042355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION WAS NOT PROVIDED BY THE REPORTER. (B)(4). THIS REPORT IS FOR ONE UNKNOWN LCP WRIST FUSION PLATE. LOT NUMBER IS UNKNOWN. TWO POSSIBLE PART NUMBERS WERE PROVIDED BY THE REPORTER: PART NUMBER 02.110.150, BRAND NAME--LCP WRIST FUSION STANDARD BEND PLATE, DEVICE PRODUCT CODE--HRS, COMMON NAME--PLATE, FIXATION, BONE, 510(K) K042355 AND PART NUMBER 02.110.151, BRAND NAME--LCP WRIST FUSION SHORT BEND PLATE, DEVICE PRODUCT CODE--HRS, COMMON NAME--PLATE, FIXATION, BONE, 510(K) K042355. OTHER¿UDI# IS UNAVAILABLE. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. THE SUBJECT DEVICE WAS STILL IMPLANTED IN THE PATIENT AS OF THE DATE OF THIS REPORT. 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. 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 FELL AND FRACTURED HIS THIRD METACARPAL IMMEDIATELY DISTAL TO A LOCKING COMPRESSION PLATE (LCP) WRIST FUSION PLATE, ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE FORTH (2.7MM) LOCKING SCREW WAS NOTED TO HAVE BACKED OUT OF THE FOURTH LOCKING HOLE IN THE PLATE; SECURED TO THE CAPITATE. THE PLATE IMPLANTED IN THE PATIENT'S WRIST APPEARED INTACT; NOT BROKEN. THIS WAS NOTED IN AN X-RAY TAKEN ON (B)(6) 2016. THE PATIENT IS CURRENTLY HEALING FROM THE FRACTURE. IT IS UNCERTAIN IF A REVISION SURGERY WILL BE PERFORMED. THIS REPORT IS FOR ONE UNKNOWN LCP WRIST FUSION PLATE. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41599 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1