BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

    MDR report key: 7266730 · Received February 13, 2018

    Report

    Report Number
    8030965-2018-51056
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    January 1, 2018
    Report Date
    January 18, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819760592
    PMA / PMN Number
    K122455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: DATE OF EVENT IS UNKNOWN. ADDITIONAL NARRATIVE: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: ARTICLE 390.008 WITH LOT 7108369 MANUFACTURED IN THE US. BRW DHR REVIEW: MFG PART NO: 390.008, LOT NO: 7108369, MFG SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 05-DEC-2012, SUPPLIER DHR: N/A. 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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PRODUCT WAS NOT RETURNED, THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE MALFUNCTIONED INTRA-OPERATIVELY UNKNOWN IF IT WAS IMPLANTED / EXPLANTED. NO MATERIAL WILL BE AVAILABLE, DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). ADDITIONAL 510K'S: K033158 - K031428. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE LARGE OPEN PEN ADJ-CLAMO MR-CONDITIONAL WAS UNABLE TO HOLD ON FIRMLY. THIS IS ALL INFORMATION THAT HAVE BEEN OBTAINED. COMPLAINT INVOLVES ONE PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111482 LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 7108369 07611819760592

    Patients

    Seq Age Sex Outcome Treatment
    1