Information was received from the healthcare professional (hcp) via manufacturer representative regarding an event that occurred during a spinal fusion procedure on a patient diagnosed with laminectomy and discectomy.It was reported that when hcp attempted to break off the set screw the set screw did not break off and continued to turn in the screw.There was a delay of approximately 30 minutes in the procedure.A revision surgery was performed for removal of set screws, rod and problem screw unilaterally and reinsertion of replacement screw, rod and set screw.The product will be returned, and was replaced with a medtronic product.No patient complications were reported.
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H3: product analysis #703889061:part # 54840005545 lot # h5522684 visual and macroscopic inspection did not reveal any thread or female torx damage.Functional evaluation with a sample break off screw found the implant able to be fully engaged and threaded into the mas head.The screw appears to be capable of performing its intended function.No fault found.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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