BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT

    MDR report key: 5124547 · Received October 2, 2015

    Report

    Report Number
    2520274-2015-16405
    Event Type
    Injury
    Date Received
    October 2, 2015
    Report Date
    September 22, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    JDP
    PMA / PMN Number
    PK110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DHR REVIEW ¿ 02.124.417 ¿ 7915741. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 22.MAY.2012. 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. 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

    DATE OF POST-OPERATIVE BREAKAGE IS UNKNOWN. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: BOTH PIECES OF THE BROKEN PLATE RETURNED IN A MINIGRIP. THE REFERENCE NUMBERS ETCHED ON THE PLATE CORRESPOND WITH THE DATA REPORTED IN THE COMPLAINT. THE RETURNED PLATE IS BROKEN IN TWO PIECES AT THE LEVEL OF THE HOLE. THE PLATE HAS BEEN IDENTIFIED BEING ARTICLE 02.124.417. THE COMPLAINT IS CONFIRMED. FROM VISUAL INSPECTION MANY OF THE HOLES ARE VISIBLY DAMAGED POST PRODUCTION AND RESULTED NOT BEING MEASURABLE. THE UNDAMAGED HOLES WERE MEASURED AND FOUND WITHIN SPECIFICATION. CONSIDERING THAT ALL THE HOLES ARE MANUFACTURED WITH THE SAME PARAMETERS AND TOOLS ALSO THE DAMAGED HOLES WERE MANUFACTURED IN ACCORDANCE WITH SPECIFICATION. ALL THE OTHER MEASURABLE FEATURES OF THE PLATE RESULTED IN SPECIFICATION. THE CONCLUSION OF THE PRODUCT INVESTIGATION IS THAT THERE IS NO EVIDENCE OF ISSUES MANUFACTURING RELATED. 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 A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2014 TO HAVE A COMPETITOR'S DEVICE REMOVED FOLLOWING A FALL AND SUBSEQUENT PERIPROSTHETIC FRACTURE. AFTER THE HARDWARE WAS REMOVED, A 16-HOLE VARIABLE-ANGLE (VA) CONDYLAR PLATE LEFT WAS IMPLANTED. SOMETIME THEREAFTER, THE PLATE BROKE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2015 TO HAVE THE BROKEN HARDWARE REMOVED. THE SURGEON INDICATED THAT THE BONE HAD NOT HEALED AND LINKED IT TO HER PAST HISTORY OF INFECTION. SWABS AND CULTURES WERE TAKEN FOR FURTHER EVALUATION. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652113 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT IMPLANT, FIXATION DEVICE, CONDYLAR PLATE JDP SYNTHES MEZZOVICO 7915741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention