BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    MDR report key: 5956870 · Received September 16, 2016

    Report

    Report Number
    2520274-2016-14557
    Event Type
    Injury
    Date Received
    September 16, 2016
    Report Date
    September 1, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODES: MNI, MNH, KWP, KWQ. THIS REPORT IS FOR (2) TWO UNKNOWN PANGEA POLYAXIAL PEDICLE SCREWS. IMPLANT DATE: UNKNOWN DATE ABOUT 10 YEARS AGO (2006). REMOVED HARDWARE WAS DISPOSED OF AT THE HOSPITAL. (B)(4): ADJACENT LEVEL DISEASE. THIS REPORT IS FOR (2) TWO UNKNOWN PANGEA POLYAXIAL PEDICLE SCREWS. (510: POSSIBLY K103287). 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. 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 HAD AN INITIAL LUMBAR SURGERY IN THE REGION BETWEEN LEVELS L1-L5 ON AN UNKNOWN DATE ABOUT 10 YEARS AGO. ON (B)(6) 2016, THE PATIENT HAD REVISION SURGERY DUE TO PAIN; THE PAIN IS ABOVE THE CONSTRUCT AT LEVEL T12-L1 LEVEL OF THE SPINE, ADJACENT LEVEL DISEASE WAS ALSO NOTICED. ALL SYNTHES HARDWARE (PANGEA CONSTRUCT) WERE REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT. NONE OF THE HARDWARE WAS REPORTED TO BE BROKEN; THE REMOVED HARDWARE WAS DISPOSED OF AT THE HOSPITAL. THERE WAS NO PATIENT INFORMATION PROVIDED. CONCOMITANT MEDICAL PRODUCTS: SYNTHES TITANIUM LOCKING SCREWS; PART NUMBERS -UNKNOWN; LOT NUMBERS - UNKNOWN; QUANTITY(8). SYNTHES POLYAXIAL PEDICLE SCREWS; PART NUMBERS -UNKNOWN; LOT NUMBERS - UNKNOWN; QUANTITY(8). THIS REPORT IS FOR (2) TWO UNKNOWN PANGEA POLYAXIAL PEDICLE SCREWS. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607384 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SYNTHES POLYAXIAL PEDICLE SCREWS, PART NUMBERS -UN| SYNTHES TITANIUM LOCKING SCREWS, PART NUMBERS -UNK