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Model Number 199721000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Neurological Deficit/Dysfunction (1982); Pain (1994); Paralysis (1997); No Code Available (3191); Unspecified Nervous System Problem (4426)
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Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unknown locking/set screws /unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.
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Event Description
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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.This complaint involves sixty-four (64) devices.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 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 and (b)(4) capture the 4 out of 64 devices reported/received.This report is for one (1) unknown locking/set screws.This report is 4it 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.This complaint involves sixty-four (64) devices.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 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 and (b)(4) capture the 4 out of 64 devices reported/received.This report is for one (1) unknown locking/set screws this report is 3 of 10 for (b)(4) 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.This complaint involves sixty-four (64) devices.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 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 and (b)(4) capture the 4 out of 64 devices reported/received.This report is for one (1) unknown locking/set screws.This report is 7 of 10 for (b)(4) of 10 for (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: e3: reporter is a synthes rep.H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.H11: d6/ capture correct date of implant.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.
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Manufacturer Narrative
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(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional product codes: mni, kwp, nkb, kwq, and osh.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.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
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Event Description
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Additionally it was reported that on (b)(6) 2018 patient a subsequent removal of spinal hardware including bilateral rods, t2 hooks bilaterally, right t5 screw and left t9 and t10.This intervention was noted for partial correction of patient's deformity.
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Search Alerts/Recalls
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