BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KWP

    MDR report key: 3554620 · Received January 6, 2014

    Report

    Report Number
    2520274-2014-00041
    Event Type
    Injury
    Date Received
    January 6, 2014
    Report Date
    December 11, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    PMA / PMN Number
    K943725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS IMPLANTED WITH A T2-ILIUM POSTERIOR SPINAL FUSION ON (B)(6) 2013 DUE TO OSTEOMYELITIS THAT HAD CAUSED SIGNIFICANT INSTABILITY AND KYPHOSIS PRIMARILY IN LUMBAR SPINE. THE PATIENT WAS INSTRUMENTED WITH USS DUAL OPENING SCREWS AND SEVERAL USS VARIABLE ANGLE SCREWS. THE SURGEON ALSO PERFORMED A L3 PEDICLE SUBTRACTION OSTEOTOMY TO REDUCE THE KYPHOSIS. THE PATIENT RETURNED TO THE SURGEON ON AN UNKNOWN DATE AFTER HAVING HEARD A POP WHILE STANDING, IN SEPTEMBER. THE SURGEON OBSERVED IN IMAGING STUDIES THAT BILATERALLY THE RODS HAD BROKEN AT THE L4-L5 LEVEL, AND THERE WAS A NON-UNION. ON (B)(6) 2013, THE PATIENT RETURNED TO THE OPERATING ROOM FOR REVISION. THE RODS WERE CUT INSITU ABOVE THE T10 PEDICLE SCREWS; NUTS AND COLLARS CAUDAL TO T9 SCREWS, REMOVED THE RODS CAUDAL TO THE T10 SCREWS, AND BENT NEW RODS TO BE CONNECTED TO THE EXISTING RODS FROM T2-T9. THE SURGEON THEN REPLACED AN UNKNOWN NUMBER OF SCREWS THAT WERE LOOSE IN THE BONE WITH A LARGER DIAMETER SCREW FROM T10-ILIUM. THE NEW RODS WERE CONNECTED TO THE EXISTING RODS USING PARALLEL CONNECTORS. NEW NUTS AND COLLARS WERE PLACED ON THE USS DUAL OPENING AND USS VARIABLE ANGLE SCREWS TO SECURE THE RODS. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 8 OF 8 FOR (B)(4).

    Description of Event or Problem · 1

    CONSULTANT REPORTED PATIENT UNDERWENT A T2-ILIUM POSTERIOR SPINAL FUSION ON (B)(6) 2013 DUE TO OSTEOMYELITIS THAT HAD CAUSED SIGNIFICANT INSTABILITY AND KYPHOSIS PRIMARILY IN LUMBAR SPINE. PATIENT WAS INSTRUMENTED WITH USS DUAL OPENING SCREWS AND SEVERAL USS VARIABLE ANGLE SCREWS. SURGEON ALSO PERFORMED A L3 PEDICLE SUBTRACTION OSTEOTOMY TO REDUCE THE KYPHOSIS. THE PATIENT RETURNED TO THE SURGEON ON AN UNKNOWN DATE AFTER HAVING HEARD A "POP WHILE STANDING" IN SEPTEMBER. SURGEON OBSERVED IN IMAGING STUDIES THAT BILATERALLY THE RODS HAD BROKEN AT THE L4-L5 LEVEL, AND THERE WAS A NON-UNION. ON (B)(6) 2013, PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REVISION. RODS WERE CUT INSITU ABOVE THE T10 PEDICLE SCREWS; NUTS AND COLLARS WERE REMOVED CAUDAL TO T9 SCREWS, REMOVED THE RODS CAUDAL TO THE T10 SCREWS, AND BENT NEW RODS TO BE CONNECTED TO THE EXISTING RODS FROM T2-T9. SURGEON THEN REPLACED UNKNOWN NUMBER OF SCREWS THAT WERE LOOSE IN THE BONE,WITH A LARGER DIAMETER SCREW FROM T10-ILIUM. THE NEW RODS WERE CONNECTED TO THE EXISTING RODS USING PARALLEL CONNECTORS. NEW NUTS AND COLLARS WERE PLACED ON THE USS DUAL OPENING AND USS VARIABLE ANGLE SCREWS TO SECURE THE RODS. SURGERY WAS SUCCESSFULLY COMPLETED. ITEM QUANTITY OF SCREW UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6546 KWP KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention