BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, PEDICLE SPINAL FIXATION

    MDR report key: 5163211 · Received October 20, 2015

    Report

    Report Number
    2520274-2015-16755
    Event Type
    Injury
    Date Received
    October 20, 2015
    Report Date
    October 7, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT INFORMATION: PATIENT HEIGHT REPORTED AS 5 FEET 11 INCHES. THE PATIENT BEGAN REPORTING SYMPTOMS OF PAIN ON (B)(6) 2015, BUT IS UNKNOWN WHEN THE REPORTED ROD BROKE. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF CLICK¿X LOCKING CAPS. A POSSIBLE PART NUMBER OF 498.570 HAS BEEN PROVIDED. POTENTIAL PART 498.570 - TI CLICK'X® LOCKING CAP FOR TI 3-D HEAD. IT IS UNKNOWN IF THIS DEVICE WAS IMPLANTED DURING THE ORIGINAL PROCEDURE ON (B)(6) 2007 OR DURING THE FIRST REVISION/EXTENSION PROCEDURE ON (B)(6) 2015. A REVISION/EXPLANT PROCEDURE (DUE TO THE BROKEN ROD) HAS NOT BEEN PERFORMED AT THIS TIME. AS SPECIFIC PART AND LOT NUMBERS FOR THE COMPLAINANT LOCKING CAP(S) WERE NOT PROVIDED. HOWEVER, A POSSIBLE 510K NUMBER IS K082572. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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

    CORRECTED DATA: THE PATIENT BEGAN REPORTING SYMPTOMS OF PAIN ON (B)(6) 2015, BUT IS UNKNOWN WHEN THE REPORTED ROD BROKE. 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

    IT WAS REPORTED THAT A PATIENT BEGAN FEELING AND HEARING A POPPING IN THE LOWER BACK ON (B)(6) 2015. THE SYMPTOMS REPORTEDLY BEGAN WHILE THE PATIENT WAS SITTING IN A CHAIR AND LEANING FORWARD TOWARDS A COMPUTER. X-RAY IMAGES AND CT SCANS TAKEN ON (B)(6) 2015 REVEALED THAT A LEFT-SIDED CLICK'X ROD HAD BROKEN. THE PATIENT REPORTED THAT THE LOWER BACK PAIN, WHICH RADIATED INTO BOTH LEGS, HAD BEEN AN ISSUE SINCE (B)(6) 2015. THERE IS CURRENTLY NO REVISION SURGERY SCHEDULED. NO ADDITIONAL INFORMATION WAS AVAILABLE. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF CLICK'X LOCKING CAPS. THIS REPORT IS 3 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATED INFORMATION INDICATES THAT THE DATE OF FEELING AND HEARING A POPPING IN THE LOWER BACK AND START OF PAIN WAS (B)(6) 2015 AND THAT AN X-RAY AND MRI CONFIRMED THE BROKEN ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692542 ORTHOSIS, PEDICLE SPINAL FIXATION MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention