BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5724779 · Received June 14, 2016

    Report

    Report Number
    2520274-2016-13157
    Event Type
    Malfunction
    Date Received
    June 14, 2016
    Report Date
    May 4, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURE: DATE SHOULD'VE BEEN 05/31/2016. 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. THIS REPORT IS FOR SCREW/UNKNOWN LOT NUMBER. OTHER: UDI: UNKNOWN PART NUMBER, UNKNOWN LOT NUMBER, UDI IS UNAVAILABLE. DEVICE IS UNKNOWN AND IS UNKNOWN IF EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. COMPLAINT IS FROM A PHILOS+ STUDY WITHOUT AUGMENTATION. THE 510K#: UNKNOWN. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: EXACT QUANTITY, MANUFACTURE OR PART/LOT UNKNOWN: THE 04.125.142S LOT. 8567128, MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 10 SEPT 2013 EXPIRY DATE: 01 AUGUST 2023. THE 04.125.144S LOT. 8570011, MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 03 SEPT 2013 EXPIRY DATE: 01 AUG 2023. THE 04.125.144S LOT. 8642559, MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 09 OCT 2013 EXPIRY DATE: 01 OCT 2023. THE 04.125.140S LOT. 8545389, MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 08 AUG 2013 EXPIRY DATE: 01 JULY 2023. THE 404.828S LOT. 8925824, MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 10 APRIL 2014 EXPIRY DATE: 01 APRIL 2024, NON-STERILE PRODUCT: 404.828 LOT 8904714, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 19 MARCH 2014. THE 404.832S LOT. 9738320, MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 24 NOV 2015 EXPIRY DATE: 01 NOV 2025, NON-STERILE PRODUCT: 404.832 LOT 9725180, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 05 NOV 2015. THE 413.028S LOT. 8960326, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 20 MAY 2014 EXPIRY DATE: 01 MAY 2024. THE 413.050S LOT. 9006223, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 12 JUNE 2014 EXPIRY DATE: 01 JUNE 2024. THE 413.044S LOT. 9010179, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 23 JUNE 2014 EXPIRY DATE: 01 JUNE 2024. THE 413.046S LOT. 9015088, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 23 JUNE 2014 EXPIRY DATE: 01 JUNE 2024. THE 413.040S LOT. 9042782, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 01 JULY 2014 EXPIRY DATE: 01 JUNE 2024. THE 413.026S LOT. 8985448, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 04 JUNE 2014 EXPIRY DATE: 01 MAY 2024. THE 413.046S LOT. 9015088, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 23 JUNE 2014 EXPIRY DATE: 01 JUNE 2024. THE 413.042S LOT. 8982429, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 27 MAY 2014 EXPIRY DATE: 01 MAY 2024. THIS IS FOR ALL ABOVE MENTIONED PARTS: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THESE PRODUCTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT 6 WEEKS TO 3 MONTHS POST-OPERATIVELY THE HEAD OF THE PHILOS IMPLANT IMPACTED. THERE WAS NO PATIENT HARM, IT WAS DISCOVERED DURING X-RAY CONSULTATION. PENETRATION OF SCREWS THROUGH THE HEAD. ARTICLES STILL IMPLANTED. PENETRATION OF SCREWS TROUGH THE HEAD. ARTICLES STILL IMPLANTED. NO HARM FOR THE PATIENT. THIS COMPLAINT INVOLVES 1 PARTS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378615 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR