PROVIDENCE MEDICAL TECHNOLOGY, INC. CAVUX CERVICAL CAGE-B; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
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Model Number PD-31-200 |
Device Problem
Malposition of Device (2616)
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Patient Problem
Neck Pain (2433)
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Event Date 08/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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This event was discovered during discussions with a surgeon who did not perform surgery on the patient.Attempts were made to contact the original surgeon via phone and email with no response received.Patient underwent posterior fusion on (b)(6) 2018 with cervical cages placed posteriorly at c6-c7 and c7-t1.However, c5-c6 and c6-c7 were intended treatment levels.Post procedure, patient complained of right arm pain initiating a ct scan.The ct scan confirmed two of four cervical cages placed posteriorly, at c6-c7 and c7-t1 on the right, were malpositioned and could be contributing to neuritis.On (b)(6) 2018, the surgeon removed one cage at c7-t1 on the right.The cervical cage at c6-c7 was found to be placed deeper than an ideal position and could contribute to right arm pain but the cervical cage at this level was not removed.Patient received an acdf at c6-c7 from another surgeon in 2019.The cervical cage at c6-c7 was not touched at this time.No device defect or malfunction or permanent impairment was reported by either surgeon.The surgeons were not able to be reached for an update on the patient but no other clinical sequelae have been documented.
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Event Description
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Patient underwent posterior fusion on (b)(6) 2018 with cervical cages placed posteriorly at c6-c7 and c7-t1.However, c5-c6 and c6-c7 were intended treatment levels.Post procedure, patient complained of right arm pain initiating a ct scan.The ct scan confirmed two of four cervical cages placed posteriorly, at c6-c7 and c7-t1 on the right, were malpositioned and could be contributing to neuritis.On (b)(6) 2018, the surgeon removed one cage at c7-t1 on the right.The cervical cage at c6-c7 was found to be placed deeper than an ideal position and could contribute to right arm pain but the cervical cage at this level was not removed.Patient received an acdf at c6-c7 from another surgeon in 2019.The cervical cage at c6-c7 was not touched at this time.No device defect or malfunction or permanent impairment was reported by either surgeon.The surgeons were not able to be reached for an update on the patient but no other clinical sequelae have been documented.
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