MEDTRONIC SOFAMOR DANEK USA, INC ELEVATE¿ SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
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Model Number 8657003 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 01/26/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 professional via field representative regarding patient with pre-op diagnosis- lumbar backache involved in the plif procedure.Levels implanted: th7/iliac.It was reported that intra-operatively, in plif of l5 / s1, cage was inserted on both sides and expanded at the same time, the tip of the inserter drive shaft used on the right side was broken.Fragment/tip of the inserter drive shaft remains in the patient's body.There were no patient symptoms reported as a result of this event.There were no further complications reported regarding the event.There was delay in overall procedure time for less than 60 minutes.No health damage in the patient was reported.Reported event was revision surgery.No mdt products used in the initial surgery.Date of initial surgery (b)(6) 2019 procedure or technique used- l3/5 tlif, th10/11 plif.
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Manufacturer Narrative
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H3: product analysis part# 8657003 ; lot# em16g011- visual inspection confirmed the entire torx tip of instrument has been sheared off.Optical examination of the fracture surface revealed a fairly flat fracture surface with circular material flow.This type of damage is consistent with torsional overload.H6: updated eval.Code method and eval.Code result post analysis updated annex g code 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.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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