BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI CANNULATED MATRIX SCREW 35MM THREAD LENGTH

    MDR report key: 3925251 · Received July 10, 2014

    Report

    Report Number
    2530088-2014-10180
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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

    (B)(4): REVIEW OF THE DEVICE HISTORY RECORDS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ADDITIONAL NARRATIVE: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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: IT WAS REPORTED THAT DURING S1 SCREW INSERTION FOR THE LUMBAR SPINAL CANAL STENOSIS CASE, THE METAL BURR WAS FOUND ON THE ENTIRE EDGE OF THE SCREW HEAD AND THE SURGEON COULD NOT RETAIN THE SCREW. THE SURGEON USED ANOTHER SCREW AND COMPLETED THE OPERATION. THERE WAS NO SCREW OR METAL BURR LEFT IN THE PATIENT BODY. THERE WAS REPORTEDLY A TWENTY MINUTE DELAY IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402953 7.0MM TI CANNULATED MATRIX SCREW 35MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 8775715

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR