BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT SPECIFIC INSTR/PLAN KTORTHOGNATHIC KIT, TWO SPLINTS

    MDR report key: 5458780 · Received February 24, 2016

    Report

    Report Number
    2520274-2016-11275
    Event Type
    Malfunction
    Date Received
    February 24, 2016
    Date of Event
    February 3, 2016
    Report Date
    February 3, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    PK103136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT AGE AND WEIGHT WERE NOT AVAILABLE FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODE IS MQN. (B)(4). IT IS UNKNOWN IF THE SUBJECT DEVICE WILL BE RETURNED FOR EVALUATION AT THE SYNTHES MANUFACTURER AT THIS TIME. 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. MFR DATE: UNKNOWN. 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. 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 THE SURGEON TOOK THE PSI (PATIENT SPECIFIC IMPLANT) ORAL SPLINTS AND TRIED TO FIT IT ON THE PATIENT IN HIS OFFICE AND FOUND IT DID NOT FIT. THIS EVENT WAS A TRIAL FITTING FOR A FUTURE SURGICAL DATE OF (B)(6) 2016. THERE WAS NO SURGICAL PROCEDURE INVOLVED WITH THE REPORTED EVENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112757 PATIENT SPECIFIC INSTR/PLAN KTORTHOGNATHIC KIT, TWO SPLINTS PLATE, BONE JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1