Model Number UNKNOWN_MEDICREA |
Device Problem
Malposition of Device (2616)
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Patient Problems
Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2015 |
Event Type
Injury
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Manufacturer Narrative
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Country: (b)(6).The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having t12-iliac and t 12-l5 thoraco-lumbar arthrodesis for an indication of degenerative scoliosis.It was reported that there was wrong positioning of the left l5 screw.The left l5 screw compressive on the l5 root with anterior l5-s1 arthrodesis and the additional treatment of lumbar arthrodesis by anterior approach and removal l5 screw was performed with 14 days of hospitalization.There were no further complications reported regarding the event.
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Manufacturer Narrative
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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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Event Description
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Additional information was received regarding the event.It was reported that the left l5 screw was wrongly placed and the patient had pain.The additional surgery was performed on (b)(6) 2015 to remove the left l5 screw.There were no further complications reported regarding the event.
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Search Alerts/Recalls
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