BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM NARROW LCP® PLATE 7 HOLES/134MM

    MDR report key: 5642436 · Received May 9, 2016

    Report

    Report Number
    9612488-2016-10229
    Event Type
    Injury
    Date Received
    May 9, 2016
    Report Date
    April 21, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HRS
    PMA / PMN Number
    PK082807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: THE PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL PACKAGING. THE LASER ETCHING WAS READABLE. THE PLATE WAS LATERAL PARTIALLY FRACTURED ON THE FOURTH HOLE AND WAS OUT OF SHAPE. THE PLATE SHOWS ABRASIONS AND SHARP EDGES. DATE SAMPLE RECEIVED AT INVESTIGATION SITE, (B)(4) 2016 A DHR REVIEW WAS PERFORMED FOR THE AFFECTED LOT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. ALL DIMENSIONS RELEVANT FOR THE FUNCTION OF THE PRODUCT WERE MEASURED, AND FULFILL THE SPECIFICATIONS. THE RAW MATERIAL CERTIFICATE WAS CHECKED. THEREFORE THE CERTIFICATE OF THE LOT, WHICH WAS CLOSEST TO THE MANUFACTURING DATE, WAS CHECKED WITH THE RESULT, THAT THE SPECIFIED RAW MATERIAL WAS PROCESSED. BASED ON THIS THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. DEVICE 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT ID, DOB & WEIGHT NOT AVAILABLE FOR REPORTING. UNKNOWN WHEN DEVICE BROKE. ADDITIONAL PRODUCT CODE: HWC. IMPLANT AND EXPLANT DATES UNKNOWN. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. THIS EVENT RESULTED IN REVISION SURGERY TO REMOVE THE BROKEN PLATE. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 25 MARCH 2003, 224.571 / 2032717. NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION AND 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.

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE RECEIPT DATE BY SYNTHES MANUFACTURER. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    PATIENT DATE OF BIRTH AND EXACT AGE ARE UNKNOWN; REPORTED AS (B)(6). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION 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

    IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE PERFORMED DUE TO FRACTURE OF A LOCKING COMPRESSION PLATE (LCP) ON PSEUDARTHROSES. THE FEMALE PATIENT OF 10 AND A HALF YEAR HAS A CONGENITAL SHORT RIGHT FEMUR. SHE UNDERWENT LENGTHENING WITH PSEUDARTHROSES WHO NEEDED A TRANSPLANT BY FIBULA AVASCULAR ILIAC. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TOTAL OF THREE PLATES HAD BROKEN POST-OPERATIVELY. A (B)(6) PATIENT HAS A CONGENITAL SHORT RIGHT FEMUR. SHE UNDERWENT A LENGTHENING PROCEDURE EXPERIENCED PSEUDARTHROSIS AND NEEDED A TRANSPLANT BY FIBULA AVASCULAR ILIAC. THE PATIENT HAD TO UNDERGO A REVISION PROCEDURE DUE TO THREE BROKEN PLATES; A SEVEN-HOLE, AN EIGHT-HOLE AND A NINE-HOLE LOCKING COMPRESSION PLATES (LCP) WERE INVOLVED. THE SEVEN-HOLE PLATE REPORTEDLY BROKE ON ONE SIDE OF THE FOURTH HOLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296796 4.5MM NARROW LCP® PLATE 7 HOLES/134MM PLATE,FIXATION,BONE HRS SYNTHES BETTLACH 2032717

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention