BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH

    MDR report key: 6273075 · Received January 24, 2017

    Report

    Report Number
    2530088-2017-10028
    Event Type
    Injury
    Date Received
    January 24, 2017
    Date of Event
    December 8, 2016
    Report Date
    January 4, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    UDI-DI
    10705034745688
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. ADDITIONAL CLASSIFICATION CODES: MNH, MNI, KWO, KWP. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART# 04.632.750 LOT# 9882155, MANUFACTURE SITE: (B)(4), MANUFACTURER DATE: 18-AUG-2015. NO NCRS OR SCRAP WAS GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS ENSURED THAT INSPECTION RECORDS AND CERTIFICATION, CONFIRMS THAT THE MATERIAL, COMPONENTS AND FINAL PRODUCT, AS APPLICABLE, MET INSPECTION RECORDS, CERTIFICATION TEST VALUES AND ACCEPTANCE CRITERIA. THIS REVIEW SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT 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: (B)(6) REPORT NUMBER: (B)(4) REPORTED THAT A POLY SCREW 7 MM X 50 MM HEAD BROKE. SURGEON WAS ABLE TO REMOVE THE OTHER PART SCREW AND REPLACE WITH A NEW SCREW. THE SCREW IS FROM MATRIX DEGEN SET. THERE IS 1 DEVICE IN THIS COMPLAINT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55660 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 Required Intervention