BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    MDR report key: 5873027 · Received August 12, 2016

    Report

    Report Number
    2520274-2016-14079
    Event Type
    Injury
    Date Received
    August 12, 2016
    Report Date
    July 27, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH AND WEIGHT ARE UNKNOWN DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN PANGEA ROD/UNKNOWN LOT NUMBER. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IT WAS REPORTED THE PART MAY BE PART NUMBER 498.158 6.0MM TI SOFT ROD 500MM, 510K: K082572, BUT THIS COULD NOT BE VERIFIED. ADDITIONAL PRODUCT CODES: MNI, MNH, KWP, KWQ. DATE OF IMPLANT: UNKNOWN. DATE OF EXPLANT: DEVICE WAS REPORTEDLY NOT EXPLANTED DURING THE REVISION PROCEDURE ON (B)(6) 2016. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THE 510K NUMBER ON INITIAL MEDWATCH REPORTED AS EXEMPT. THIS WAS REPORTED IN ERROR. PART NUMBER FOR ROD IS UNKNOWN SO 510K NUMBER IS UNKNOWN. 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. 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 THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 DUE TO A NON-UNION FAILED FUSION RECONSTRUCTION OF THE ANTERIOR COLUMN AND A BROKEN PANGEA ROD. THIS REVISION SURGERY WAS NOT PART OF THE PATIENT'S ORIGINAL TREATMENT PLAN. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THE SURGEON DECIDED TO USE AN IN-LINE CONNECTOR TO RECONNECT THE HARDWARE AS THE PANGEA EVALUATION SET WAS NOT AVAILABLE AT THE TIME OF THE SURGERY. NONE OF THE PREVIOUS IMPLANTS WERE REMOVED. THERE WAS NO SURGICAL TIME DELAY AND NO OTHER MEDICAL INTERVENTION REQUIRED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS OUTCOME IS STABLE. THIS REPORT IS FOR AN UNKNOWN PANGEA ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ORIGINAL IMPLANTS WERE USED FOR THE PATIENT'S SCOLIOSIS. IT WAS CONFIRMED THE BROKEN ROD WAS EXPLANTED DURING THE REVISION PROCEDURE; THE DEVICE REMAINS IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPORTER IS NOT SURE IF THE PATIENT HAD ANY PRESENTING SYMPTOMS PRIOR TO THE REVISION. THE LEVEL OF THE NON-UNION WAS LOCATED AT T11 AND T12. IT WAS A LEFT SIDE ROD THAT BROKE. THE SURGEON WAS AWARE THAT THE PANGEA EVALUATION SET DID NOT ARRIVE IN TIME FOR THE PROCEDURE AND DECIDED TO PROCEED INSTEAD OF RESCHEDULING; AND THE SURGEON DID NOT USE ANY PANGEA INSTRUMENTATION TO FINISH THE PROCEDURE, ONLY A CONNECTOR TO RE-CONNECT THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523736 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention