BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOCKING SCREW

    MDR report key: 2971061 · Received February 21, 2013

    Report

    Report Number
    1719045-2013-00394
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWP
    PMA / PMN Number
    K091689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT NO. 5756309 REVEALED THE T15 DRIVE SET SCREW WAS MANUFACTURED AND INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER ON (B)(4) 2008. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 5/5/2008; 229 PARTS WERE RELEASED TO THE WAREHOUSE ON 5/6/2008. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORTED DATE OF IMPLANT WAS IN 2008, DATE UNKNOWN. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH OCCIPITAL PLATE, RODS, AND SCREWS ON AN UNKNOWN DATE IN 2008. PATIENT PRESENTED WITH PAIN AND BROKEN SPINE HARDWARE FROM A PREVIOUS FUSION. IT WAS REPORTED, THE OCCIPITAL PLATE WAS CRACKED AT THE JUNCTION WHERE BOTH RODS ATTACH TO THE PLATE. ONE SCREW THAT WAS IMPLANTED IN THE LATERAL MASS ON THE RIGHT SIDE OF C2 HAD A BROKEN SHAFT JUST BELOW HEAD OF THE SCREW. THE 3.5 SYNAPSE ROD WAS ALSO BROKEN ON THE LEFT SIDE BETWEEN THE OCCIPUT AND C2. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 TO REMOVE ALL THE POSTERIOR SPINE HARDWARE. PATIENT WAS REVISED WITH LARGER SYNAPSE 4.0 SYSTEM FROM OCCIPUT TO C7. THIS IS 4 OF 12 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75488 TI LOCKING SCREW LOCKING SCREW KWP SYNTHES MONUMENT 5756309

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention