Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for l4/5 stenosis.Levels implanted : l4/5 it was reported that when the final cross link tightening was performed, the center screw was loose and could not be tightened.It might be too loose, but just in case, the product was replaced. there was no patient symptom reported.There were no further complications reported regarding the event.Additional information: procedure involved : plf the event occurred in the surgical field.The product came in contact with the patient.
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H3: product analysis : part # g9010001550, lot # h5728872 visual and optical inspection did reveal some nicks and deformation to the crosslink.The center nut that threads onto the crosslink has been cross threaded.The threads have been stripped.The female hex on both of the break off set screws has been damaged/stripped.The can no longer be removed.This type of damage is consistent with torsional overload and misalignment of the threads when attaching the net.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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