BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM NARROW LCP® PLATE 10 HOLES/188MM

    MDR report key: 3840398 · Received May 30, 2014

    Report

    Report Number
    3009450884-2014-10019
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    PMA / PMN Number
    PK082807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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. 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: A MANUFACTURING EVALUATION WAS COMPLETED: THE LOCKING COMPRESSION PLATE (LCP) BROKE THROUGH THE FIFTH PROXIMAL COMBINATION PLATE HOLE. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, IT IS LIKELY THAT THE IMPLANT WAS SUBJECTED TO LOW DYNAMIC BENDING LOADS. CONSTANTLY ALTERNATING LOAD CYCLES LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE LCP. THE PLATE COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD / FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE TOO. NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS WAS FOUND. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE FIRST SURGERY WAS PERFORMED ON (B)(6) 2014. THE DOCTOR BENT THE PLATE ONCE AT THE POINT WHERE THE PLATE WAS BROKEN. THE MOTHER REPORTS OF TWO FALLS ON THE STAIRS, BUT ON THE HEALTHY LEG. THE PATIENT SPENT MOST OF HIS TIME IN THE WHEELCHAIR AND NEVER COMPLAINED ABOUT PAIN. DURING THE PLANNED 6 WEEKS POST-OP CONTROL, THE SURGEON FOUND THE BROKEN OFF PATE ON AN X-RAY CHECK. THE PLATE WAS REMOVED AND REPLACED WITH A LONGER 11-HOLES PLATE ON (B)(6) 2014. ADDITIONALLY, THE DOCTOR FOUND IN THE X-RAYS DATED (B)(6) 2014, A RADIOLUCENT LINE PRECISELY IN THE REGION OF THE FRACTURE OF THE PLATE. A PROLONGATION OF HOSPITAL STAY WAS ALSO REPORTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST SURGERY WAS PERFORMED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318429 4.5MM NARROW LCP® PLATE 10 HOLES/188MM PLATE, FIXACTION, BONE HRS SYNTHES GRENCHEN 2714020

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| R