BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI PANGEA(TM) LOCKING CAP

    MDR report key: 5377606 · Received January 19, 2016

    Report

    Report Number
    2520274-2016-10322
    Event Type
    Injury
    Date Received
    January 19, 2016
    Report Date
    January 5, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PATIENT WEIGHT IS UNKNOWN. ADDITIONAL PRODUCT CODES: MNI, MNH, KWP AND KWO. (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A T12-ILIUM POSTERIOR SPINAL FUSION WITH SYNTHES PANGEA AND SYNTHES ILIOSACRAL IN 2010 ON AN UNKNOWN DATE. AT AN UNKNOWN POINT IN TIME THE PATIENT DEVELOPED STENOSIS AND ADJACENT LEVEL DISC DISEASE CRANIAL TO THE FUSION; IT WAS ALSO REPORTED THE PATIENT HAD PAIN, IRRITATION OR DISCOMFORT. ON (B)(6) 2016 THE SURGEON PERFORMED THE REVISION SURGERY TO ADDRESS THE STENOSIS ABOVE THE LEVEL OF THE FUSION. THE SURGEON REMOVED ALL THE PANGEA HARDWARE FROM T12-S1 AND THE SYNTHES ILIOSACRAL FROM THE ILIUM. THERE WAS NO ISSUE WITH THE HARDWARE FROM THE 2010 SURGERY. A NON-SYNTHES CONSTRUCT WAS PLACED FROM T9 - L2, DECOMPRESSION WAS PERFORMED FROM T9 - T11 AND THE SURGEON DID NOT INSTRUMENT THE LEVELS CAUDAL TO L2 AS THE PATIENT HAS A SOLID FUSION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34678 TI PANGEA(TM) LOCKING CAP ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention