BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 8643512 · Received May 27, 2019

    Report

    Report Number
    1030489-2019-00581
    Event Type
    Injury
    Date Received
    May 27, 2019
    Report Date
    May 27, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    LOT #, PART #, UDI #, 510K: THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: CERVICAL FUSION DEVICES: PRODUCT ID: 9790023, LOT# UNK, 510K: K042922, UDI# (B)(4), QTY: 1. PRODUCT ID: 9790313, LOT#: UNK, 510K: K042922, UDI# (B)(4), QTY: 4. PRODUCT ID: UNKNOWN ROD, LOT# UNK, QTY: 2. LUMBAR FUSION DEVICES: PRODUCT ID: 2991232, LOT# H10J1698, 510K: K073291, UDI# (B)(4), QTY: 1. PRODUCT ID: UNKNOWN SET SCREW, LOT#: UNK, QTY: 6. PRODUCT ID: UNKNOWN SCREW, LOT#: UNK, QTY: 6. ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. IMPLANT DATES: ON (B)(6) 2005: CERVICAL FUSION (MONTH AND YEAR VALID ); ON (B)(6) 2011: LUMBAR FUSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT ITSELF THAT THE PATIENT UNDERWENT CERVICAL FUSION SURGERY IN (B)(6) 2005 DUE TO SOME UNKNOWN REASONS. PO ST-OP, THE PATIENT HAS HAD PAIN IN NECK, JAWS, ALLERGIES ETC EVER SINCE THE SURGERY. 6 WEEKS AFTER THE SURGERY, THE PATIENT STARTED TASTING METAL ALL THE TIME. ALLERGIES STARTED ABOUT A YEAR AND A HALF LATER. PAIN IN NECK STARTED ABOUT 1 MONTH AFTER THE ALLERGIES STARTED. PATIENT SUSPECTS THAT IT¿S THE IMPLANTED DEVICES CAUSING THE ISSUES. HE SAID THAT THE BLOOD/ALLERGY TESTS SHOW THAT HE¿S ALLERGIC TO COBALT, NICKEL, IRON AND ZIRCONIUM. LATER THE PATIENT UNDERWENT LUMBAR SURGERY AS WELL ON (B)(6) 2011. ON (B)(6) 2011: THE PATIENT WAS PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: NEUROGENIC CLAUDICATION, SPONDYLOLISTHESIS, LUMBAR STENOSIS. HE UNDERWENT FOLLOWING PROCEDURES: INFERIOR LAMINECTOMY OF L2 AND DECOMPRESSION; L3 LAMINECTOMY AND FORAMINOTOMY; L4 LAMINECTOMY AND FORAMINOTOMY; L5 LAMINECTOMY AND FORAMINOTOMY; L3-4 POSTEROLATERAL ARTHRODESIS; L4-5 POSTEROLATERAL ARTHRODESIS; L4-5 POSTERIOR INTERBODY ARTHRODESIS; SEGMENTAL INSTRUMENTATION USING SCREWS; INTERBODY DEVICE L4-512 X 32 MM CAGE; LOCAL BONE GRAFT HARVEST PREPARATION. POST-OP SYMPTOMS: FATIGUE, ALLERGY TYPE (RUNNING NOSE, WATERY EYES, SNEEZING, COUGHING, SORE THROAT, PAIN IN THROAT). PATIENT AFTER HIS BACK SURGERY HAD BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437242 APPLIANCE, FIXATION, SPINAL INTERLAMINAL APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other