BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LOCKING SCREW SELF-TAPPING 40MM

    MDR report key: 5389207 · Received January 25, 2016

    Report

    Report Number
    9612488-2016-10045
    Event Type
    Injury
    Date Received
    January 25, 2016
    Report Date
    January 7, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    KTT
    PMA / PMN Number
    PK000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT AGE WAS NOT PROVIDED BY REPORTER. THE DATE OF EVENT WAS REPORTED AS (B)(6) 2015; AND THE ALERT DATE REPORTED AS (B)(6) 2015, HOWEVER, IT IS UNCLEAR IF THIS WAS THE DATE THE INFECTION WAS CONFIRMED OR THE DATE THE SYMPTOMS BEGAN. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. (B)(6). MEDICAL INTERVENTION NEEDED TO TREAT INFECTION. THE 510(K): UNKNOWN. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), 413.040S / 9042782, MANUFACTURING DATE: 07 JULY 2014, EXPIRY DATE: 01 JUNE 2024, NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE 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

    (B)(4). 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

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A DEEP WOUND INFECTION REQUIRED SURGERY FOR DEBRIDEMENT ((B)(6) 2015). ANTIBIOTICS, ANTICOAGULANTS (CLEXANE), ANALGESICS AND INTENSIVE CARE UNIT FOR PHYSIOTHERAPY. RECOVERY IN PROGRESS. AS IT IS NOT KNOWN WHAT KIND OF SURGERY FOR DEBRIDEMENT WAS DONE (UNKNOWN IF THE WOUND NEEDED TO BE OPENED AGAIN) AND AS TWO DATES ARE MENTIONED A SECOND COMPLAINT FILE WAS OPENED TO DOCUMENT THE SECOND INTERVENTION ON (B)(6) 2015. PATIENT HAD AN INFECTION ON THE PHILOS PLATE AND THE PLATE HAS BEEN REMOVED AND SHE RECEIVED ANTIBIOTICS. THIS REPORT IS 7 OF 17 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48076 3.5MM TI LOCKING SCREW SELF-TAPPING 40MM APPLIANCE,FIXATION,NAIL KTT SYNTHES BETTLACH 9042782

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention