BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX REDUCTION SCREW 50MM THREAD LENGTH

    MDR report key: 5025261 · Received August 24, 2015

    Report

    Report Number
    3000270450-2015-10168
    Event Type
    Malfunction
    Date Received
    August 24, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 11, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. DEVICE WAS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE STERILE AND NON-STERILE PART WAS COMPLETED: STERILE ARTICLE INFORMATION, NO DEVIATION WAS FOUND. MANUFACTURING LOCATION: SELZACH. MANUFACTURING DATE: 12MARCH2012. EXPIRY DATE: 01FEBRUARY2022. THE NON-STERILE ARTICLE 04.634.750 LOT 6860561 WAS MANUFACTURED IN MONUMENT. BRANDYWINE DHR REVIEW: MANUFACTURE DATE: 18JANUARY2012. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE MATRIX SPINAL SYSTEM WAS APPLIED FOR SPINAL CANAL STENOSIS AT REGION FROM L5 TO SACRUM. THE SURGEON INSERTED THE REPORTED REDUCTION SCREW IN LEFT S1 BUT IT WAS CUT OFF. THE SURGEON REMOVED THE SCREW AND TRIED TO EQUIP IT WITH THE DRIVER BUT WITHOUT SUCCESS. WHEN THE SURGEON CHECKED THE REPORTED SCREW AND SLEEVE, THE SURGEON FOUND THAT THE TIP OF THE REPORTED RETAINING SLEEVE WAS BROKEN AND ITS FRAGMENT REMAINED BEING WITH THE SCREW. NO SURGICAL DELAY WAS REPORTED. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557282 7.0MM TI MATRIX REDUCTION SCREW 50MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES SELZACH 7808967

    Patients

    Seq Age Sex Outcome Treatment
    1