BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    MDR report key: 5968115 · Received September 21, 2016

    Report

    Report Number
    2520274-2016-14623
    Event Type
    Injury
    Date Received
    September 21, 2016
    Report Date
    September 2, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CLASSIFICATION CODES: MNI, MNH, KWP, KWP. THIS REPORT IS FOR UNKNOWN PANGEA RODS/UNKNOWN LOT NUMBER. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PANGEA HARDWARE REMAINS IN THE CUSTODY OF THE HOSPITAL FACILITY, AND WILL NOT BE RETURNED (B)(4): THIS WILL BE REPORTED AS A POTENTIAL DEVICE-RELATED EVENT. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 WAS TREATED ON AN UNKNOWN DATE WITH SYNTHES PANGEA INSTRUMENTATION AT LEVELS L4-S1 FOR DEGENERATIVE DISC DISEASE. AT AN UNKNOWN TIME, IT WAS NOTED THAT THE PATIENT DEVELOPED ADJACENT LEVEL DEGENERATIVE DISC DISEASE AT L3-L4. THERE WAS NO ALLEGATION OF DEFICIENCY IN THE EXISTING PANGEA HARDWARE, AND FUSION HAD BEEN ACHIEVED AT L4-S1. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2016. ALL PANGEA HARDWARE WAS REMOVED INTACT, AND THE PATIENT WAS IMPLANTED WITH MATRIX INSTRUMENTATION AT LEVEL L3-L4. NO HARDWARE WAS REIMPLANTED AT L4-S1. THERE WAS NO SURGICAL DELAY, NO BROKEN HARDWARE, AND NO EVIDENCE OF LESS THAN DESIRABLE TREATMENT OUTCOME FROM THE ORIGINAL SURGERY. PATIENT STATUS WAS REPORTEDLY STABLE FOLLOWING THE PROCEDURE. THE PANGEA HARDWARE REMAINS IN THE CUSTODY OF THE HOSPITAL FACILITY, AND WILL NOT BE RETURNED. CONSULTANT CONFIRMS ALL KNOWN INFORMATION HAS BEEN PROVIDED. CONCOMITANT MEDICAL PRODUCTS: 4 UNKNOWN PANGEA SCREWS (UNKNOWN PART #, UNKNOWN LOT #, QUANTITY 4); 4 UNKNOWN PANGEA LOCKING CAPS (UNKNOWN PART #, UNKNOWN LOT #, QUANTITY 4). THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619006 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention 4 UNKNOWN PANGEA LOCKING CAPS UNK PART #, UNK LOT#| 4 UNKNOWN PANGEA SCREWS UNK PART #, UNK LOT #