BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 2386118 · Received December 22, 2011

    Report

    Report Number
    1030489-2011-01634
    Event Type
    Injury
    Date Received
    December 22, 2011
    Date of Event
    December 13, 2011
    Report Date
    December 13, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    MAX
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: CORRECTED INFORMATION RECEIVED; PARTS WILL NOT BE RETURNED AS ORIGINALLY STATED. THE BROKEN IMPLANT WAS DISCARDED AND THEREFORE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 2991026, PRODUCT CODE MAX WAS CLEARED IN THE UNITED STATES. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 2991026, 510K # K073291 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE. IT WAS REPORTED THAT THE CAGE WAS INSERTED INTO DISC SPACE AT L3-L4. UPON TRYING TO REPOSITION THE CAGE WITH THE REMOVAL DEVICE, A PORTION OF THE CAGE BROKE OFF AND WAS LEFT IN THE PATIENT. IT WAS NOTED THAT THE PATIENT HAD A PREVIOUS SURGERY AT L5-S1. THAT LEVEL WAS FUSED PRIOR TO THIS OPERATION. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE SPINAL SYSTEM MAX MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS 2991026INT H11A4186

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR