Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient who underwent l3/4/5 2 intervertebral transforaminal lumbar interbody fusion (tlif) for lumbar spinal stenosis.It was reported that after the final cross-link conclusion, an attempt was made to remove the cross-link to change the installation position of the cage, but the set screw on the side of the cross-link got stripped, so the cross-link cannot be detached from the rod.The cross-link and rod were removed as a unit.No further complications or symptoms were reported.Additional information was received via manufacturer representative that there is no specific allegation against rod and all the reported products came in contact with the patient.Additional information was received via manufacturer representative that there is no malfunction on driver.
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H3: product analysis - product#: g9010001550 lot#: h5724665 the threads on the end of one of the break off screws is damaged.The thread has started to peal away from the shaft of the screw.The hex of the opposite side has stripped.This is consistent with overload.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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