BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 4937560 · Received July 23, 2015

    Report

    Report Number
    2530088-2015-10521
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 10, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS COMPLETED: IT WAS REPORTED THAT METAL SHAVINGS CAME OFF THE TITANIUM MATRIX LOCKING CAP (04.632.000 LOT 7991601) WHEN TRYING TO THREAD IT INTO A 3D HEAD. THE RETURNED IMPLANT WAS INSPECTED UNDER MAGNIFICATION AND THE THREADS WERE FOUND TO BE INTACT AND WITHOUT DEFORMATION; ALL OF THE ANODIZED COATING REMAINED. THE COMPLAINT IS UNCONFIRMED. THE RETURNED IMPLANT WAS EXAMINED UNDER MAGNIFICATION WHERE THE THREADS WERE FOUND TO BE IN GOOD CONDITION (I.E. NOT DEFORMED, NO MISSING FRAGMENTS, NO ANODIZATION COATING WORN AWAY). BASED ON THE CONDITION OF THE RETURNED LOCKING CAP IT IS LIKELY THAT THE FRAGMENTS NOTED IN THE COMPLAINT DESCRIPTION ORIGINATED FROM THE SCREW RATHER THAN LOCKING CAP. AS NO PRODUCT FAULTS WERE FOUND WITH THE RETURNED IMPLANT, NO FURTHER INVESTIGATION IS REQUIRED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THERE WERE NO ISSUES FOUND WITH THE RETURNED DEVICE. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INITIALS ARE (B)(6). PATIENT INFORMATION WAS NOT PROVIDED BY REPORTER. ADDITIONAL DEVICE PRODUCT CODES ARE: MNH, MNI, KWQ AND KWP. SUBJECT DEVICE WAS NOT IMPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    IT WAS REPORTED THAT METAL SHAVINGS CAME OFF THE TITANIUM MATRIX LOCKING CAP WHEN TRYING TO PUT IT INTO 3D HEAD. THERE WAS A 5 MINUTE SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479447 TI MATRIX LOCKING CAP ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 7991601

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR