Information was received from a healthcare professional (hcp) via a medtronic representative regarding patient implanted with a spinal product using an inserter for a l5-s1 tlif extension and revision of hardware at l3-l5.It was reported that the side metal pieces of the elevate inserter that hug the elevate cage broke off.According to the physician, both pieces were extracted.The instrument broke and there was no fragment of the instrument remaining in the patient's body.There were no patient symptoms or complications as a result of the event.The product was used in operation field and came in contact with the patient.The pre-op diagnosis was lumbar instability neurogenic claudication due to lumbar spinal stenosis and levels implanted were l5-s1.There was no treatment or additional surgery performed as a result of this event.The product was replaced by a medtronic product.The patient's medical history included diabetes, blood pressure, arthritis.No further complications were reported/ anticipated.
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D4: updated udi# h3: product analysis part# nav2132, lot# dn19h001- visual and optical inspection confirmed that both of the prongs at the tip of the inserter have been broken off.This type of damage is consistent with bend stress overload.H6: updated eval.Code method and eval.Code result post analysis 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.
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