This report is for an unknown rod/ unknown lot.
Part and lot numbers are unknown; udi number is unknown.
Without a lot number the device history records review could not be completed.
Product was not returned.
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.
|
It was reported that on (b)(6) 2015, the patient presented with the complaints of shoulder pain which revealed scoliosis obtained on radiological studies.
However, they failed to diagnose scoliosis or have the patient scoliosis evaluation.
On (b)(6) 2018, the patient came with the complaints of upper back pain primarily in the left-mid-thoracic spine radiating to the left and right buttocks.
The pain was intermittent, moderate ache with no history of back pain before.
On (b)(6) 2018, the patient explained that he had low back pain and occasional thigh pain.
The patient denied of radiating pain, numbness or tingling in her extremities.
The patient was scheduled then with posterior instrumented fusion t2 to l4 vertebral bodies.
The need for the surgery was urgent because it was not detected earlier.
On (b)(6) 2018, the surgeon recommended and agreed to have urgent surgery to the patient with more conservative treatment.
On (b)(6) 2018, they began the surgery (posterior instrumented fusion t2 to l4.
But when the patient awoke from the surgery, the patient was completely paralyzed from her chest down with the motor-sensory loss from t4 to her toes.
And now suffers from dysreflexia.
No further information available.
This report is for one (1) unknown rod.
This is report 1 of 10 for (b)(4).
This (b)(4) capture the 10 out of 64 devices reported/ received, (b)(4) capture the 10 out of 64 devices reported/ received, (b)(4) capture the 10 out of 64 devices reported/ received, (b)(4) capture the other 10 out of 64 devices reported/ received, (b)(4) capture the 10 out of 64 devices reported/ received, (b)(4) capture the 10 out of 64 devices reported/ received and (b)(4) capture the 4 out of 64 devices reported/ received.
|