BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI LCP ULNA OSTEOTOMY PLATE/6 HOLES-STERILE

    MDR report key: 4812134 · Received June 2, 2015

    Report

    Report Number
    2520274-2015-14176
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    May 7, 2015
    Manufacturer
    SYNTHES RARON
    Product Code
    HRS
    PMA / PMN Number
    PK113364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION WAS NOT PROVIDED BY REPORTER. ADDITIONAL DEVICE PRODUCT CODE¿HWC. EXPLANT DATE IS UNKNOWN. (B)(4). 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. THE SUBJECT DEVICE HAS REPORTEDLY BEEN DISCARDED. 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

    UPDATED INFORMATION CONFIRMED THAT AN AFFILIATE FACILITY IN ITALY RECEIVED THE DEVICE. AS OF YET, THE COMPLAINANT PART HAS NOT BEEN RETURNED TO THE MANUFACTURING INVESTIGATION SITE FOR REVIEW. 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 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

    NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 1

    AN INTERNAL REVIEW OF THE RECEIVED X-RAYS WAS COMPLETED BY A DEPUY SYNTHES MEDICAL DIRECTOR WITH RESULTS AS FOLLOWS: "MOVEMENT CERTAINLY APPEARS TO HAVE OCCURRED AT THE OSTEOTOMY SITE AS DESCRIBED."

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT 20 DAYS AFTER A 6-HOLE PLATE WAS IMPLANTED IN THE PATIENT DURING AN ULNAR OSTEOTOMY PROCEDURE, A SECONDARY ROTATION DISLOCATION OF THE LIMB OCCURRED. SECONDARY INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FIVE SCREWS WERE IMPLANTED. THE PATIENT UNDERWENT SHOCK WAVE THERAPY, WHICH HAS ENDED. AFTER THE NEXT X-RAY RESULTS, HOW TO PROCEED WILL BE DECIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357039 2.7MM TI LCP ULNA OSTEOTOMY PLATE/6 HOLES-STERILE PLATE, FIXATION, BONE HRS SYNTHES RARON 7570854

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention