BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX LOCKING CAP WITHOUT SADDLE

    MDR report key: 5971189 · Received September 22, 2016

    Report

    Report Number
    2530088-2016-10256
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 6, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K120838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MANUFACTURING DATE: APRIL 27, 2016. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE MATRIX LOCKING CAP ( PART NUMBER 09.632.099, LOT NUMBER H090628). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE IMPLANT SHOWS UNKNOWN RESIDUES (MOST PROBABLY FROM THE SURGERY), WHICH COULD NOT BE REMOVED DURING DECONTAMINATION AND ADDITIONALLY A SMALL METAL CHIP WAS RETURNED. THEREFORE, ONLY A VISUAL INSPECTION IS POSSIBLE. THE COMPLAINT CONDITION WAS CONFIRMED. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A POINT OF REFERENCE FOR THE METAL CHIP WAS NOT DETERMINED. THE CHIP COULD ALSO BE FROM ANOTHER IMPLANT OR INSTRUMENT. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. BASED ON THESE FINDINGS AND AS NO ORIGINALLY FAULT WAS FOUND, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. FRAGMENT IS NOT AN IMPLANT AND IS NOT IMPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    CONCOMITANT DEVICE: SCREW (PART/LOT UNKNOWN, QUANTITY 1); ROD (PART/LOT UNKNOWN, QUANTITY 1).

    Description of Event or Problem · 1

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2016 DURING A SPINE SURGERY , A FRAGMENT WAS NOTICED AFTER THE SURGEON HAD SET THE ROD UP AND SUBSEQUENTLY, TOOK OFF SET-SCREWS TO RESET THE SYSTEM. A NURSE NOTICED A METAL FRAGMENT ON THE SET-SCREWS. THE FRAGMENT WAS REMOVED SUCCESSFULLY. THE SURGERY WAS EXTENDED FOR 15 MINUTES DUE TO THE EVENT. NO PATIENT HARM WAS REPORTED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES 1 PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621075 MATRIX LOCKING CAP WITHOUT SADDLE ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE H090628

    Patients

    Seq Age Sex Outcome Treatment
    1