WARSAW ORTHOPEDICS VERTEX® RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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Model Number G7752536 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This part is not approved for use in the united states; however, a like device catalog # 7752535, 510k #k082728, udi#: (b)(4) was cleared in the united states.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 the healthcare professional (hcp) via the manufacturer representative regarding an event which occurred during an c4-th2 posterior fusion procedure in a patient diagnosed with c6 dislocation fracture.It was reported that after placing crosslink on c6 and temporarily tightening it the set screw of the rod crosslink stripped during the final tightening, so it was replaced with a new crosslink (same size).There was a delay of less than 60 mins in the overall procedure.No patient injury / complication was reported.
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Manufacturer Narrative
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H3: part no.: g7752536 lot# 0807676w visual and optical examination revealed the female hex edges have been rounded/deformed.There were no signs of thread damage on the set screw.The threads appear to be used but no signs of cross threading.The damage to the hex appears to be from torsional 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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