COMMON DEVICE NAME: SPINAL MESH SYSTEM (SPINAL VERTEBRAL BODY REPLACEMENT DEVICE). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9050713, 510K #K011406, (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. ALTHOUGH IT IS UNKNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OR NOT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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Patient 1
PRE-OPERATIVE DIAGNOSIS: CERVICAL SPONDYLOTIC RADICULOPATHY(CSR) PROCEDURE: ANTERIOR CERVICAL DECOMPRESSION AND FUSION (ACDF), C5 SUBTOTAL REMOVAL, SURGICAL APPROACH PLACEMENT OF PRODUCT: INSIDE INTERVERTEBRAL DISC SPACE POSTEROLATERAL IT WAS REPORTED THAT BLEEDING FROM DEEP AREA OF EPIDURAL VENOUS PLEXUS OCCURRED DURING INSERTING DEVICE. BECAUSE WHILE INSERTING THE DEVICE, IT WAS NECESSARY TO HAMMER IT IN, SO MAYBE THE VEIN PLEXUS GOT INJURED AT THAT TIME. OR MAYBE THE VEIN PLEXUS GOT INJURED WHEN PERFORMING DECOMPRESSION. TREATMENT HAS BEEN GIVEN TO STOP BLEEDING, THE PATIENT RETURNED FROM THE OPERATION ROOM AND THEN THERE WAS NAUSEA, AND A DRUG TO STOP NAUSEA WAS GIVEN TO THE PATIENT. AFTER THAT, THE PATIENT'S BREATHING BECAME UNSTABLE, THE PATIENT COULD NOT RESPOND WHEN SOMEONE WAS TALKING TO THE PATIENT, AND THE PATIENT BECAME UNABLE TO SAY A WORD. AFTER INTUBATION AND ADMINISTRATION OF STEROID ETC., THE PATIENT'S AWARENESS BECAME CLEAR. THE PATIENT COULD WALK NOW AND WAS RECOVERING.