BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 3803263 · Received May 9, 2014

    Report

    Report Number
    2520274-2014-11399
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    March 18, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES/UNKNOWN LOT. THE RANGE OF PARTS FOR THE 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATE (STAINLESS STEEL) MAY BE: 02.123.020 TO 02.123.033 AND 02.123.040 TO 02.123.043. THE RANGE OF PARTS FOR THE 3.5MM TITANIUM LCP PERIARTICULAR PROXIMAL HUMERUS PLATE MAY BE 04.123.020 TO 04 -123.033 AND 04.123.040 TO 04.123.043. IT IS UNKNOWN IF THE DEVICE(S) WERE IMPLANTED AND/OR EXPLANTED. 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. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN 3.5MM LOCKING COMPRESSION PLATE PERIARTICULAR PROXIMAL HUMERUS PLATES/UNKNOWN LOTS. POSSIBLE PART NUMBERS: 02.123.020 THROUGH 02.123.031, 02.123.032S, 02.123.033S, 02.123.040 THROUGH 02.123.043. ALL POSSIBLE PART NUMBERS HAVE PRODUCT CODE: HRS PLATE, FIXATION, BONE. ALL POSSIBLE PART NUMBERS HAVE A 510K NUMBER OF K082625. 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) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ONE OR MORE PERIARTICULAR PROXIMAL HUMERUS PLATES POSSIBLE BROKE. NO FURTHER INFORMATION WAS PROVIDED. THERE WERE NO SPECIFIC PATIENT DETAILS OR EVENTS REPORTED. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282015 PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1