BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH

    MDR report key: 6329724 · Received February 14, 2017

    Report

    Report Number
    2530088-2017-10040
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Date of Event
    December 8, 2016
    Report Date
    January 19, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    UDI-DI
    10705034745688
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODES: MNH, MNI, KWQ, KWP. DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT FULLY IMPLANTED OR EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS PART WAS DISCARDED BY THE FACILITY. (B)(6). DEVICE HISTORY RECORD (DHR) REVIEW REQUEST: PART # 04.632.750, LOT # 9882155: MANUFACTURE SITE: (B)(4), MANUFACTURE DATE: 18-AUG-2015. NO NON CONFORMANCE REPORTS (NCRS) OR SCRAP 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 ACTION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN INITIAL DEGENERATIVE LUMBAR POSTERIOR FUSION ON (B)(6) 2016, THE HEAD OF A 7.0 MM TITANIUM MATRIX POLYAXIAL SCREW 50 MM THREAD LENGTH CAME OFF OF THE SHAFT OF THE SCREW AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING A SAME/LIKE PRODUCT. SURGICAL DELAY AND PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN INSTRUMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111496 7.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 9882155 10705034745688

    Patients

    Seq Age Sex Outcome Treatment
    1 ONE (1) UNKNOWN INSTRUMENT