BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

    MDR report key: 6527405 · Received April 27, 2017

    Report

    Report Number
    2520274-2017-11538
    Event Type
    Malfunction
    Date Received
    April 27, 2017
    Date of Event
    April 3, 2017
    Report Date
    April 4, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DZL
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). NO LOT NUMBER WAS PROVIDED, WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 MALFUNCTION OCCURRED INTRAOPERATIVE. DEVICE WAS NOT IMPLANTED/EXPLANTED. DEVICE IMPLANT DATE WAS REPORTED AS (B)(6) 2017 IN INITIAL MW IN ERROR. ADDITIONAL DEVICE PRODUCT CODES USED JEY. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO REMOVE A MATRIX MIDFACE SCREW IN ORDER TO RE-POSITON / RE-PLACE THE PLATE, THE HEAD OF THE SCREW BROKE OFF. THE SCREW SHAFT WAS LEFT INTO THE PATIENT'S BONE. NO PROLONGATION OF SURGERY OCCURRED. DATE OF IMPLANT WAS ON (B)(6) 2017. DATE OF EVENT WAS ON (B)(6) 2017. NO INFORMATION ABOUT PATIENT OUTCOME. COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, WHEN THE SURGEON TRIED TO REMOVE A MATRIX MIDFACE SCREW IN ORDER TO RE-POSITON / RE-PLACE THE PLATE, THE HEAD OF THE SCREW BROKE OFF. THE SCREW SHAFT WAS LEFT INTO THE PATIENT'S BONE. NO PROLONGATION OF SURGERY OCCURRED. NO INFORMATION ABOUT PATIENT OUTCOME WAS REPORTED. CONCOMITANT DEVICE REPORTED: PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308078 TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM SCREW FIXATION INTRAOSSEOUS DZL SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR