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Model Number PK1002 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 07/15/2022 |
Event Type
malfunction
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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 l4/5 tlif for an indication of lumbar spinal stenosis.It was reported that after the pak needle was inserted to the left of l5, the inner cylinder was removed, and the gw was inserted, when the outer cylinder of the pak needle was removed, it broke on the part where the 4cm thickness changes from the tip of the pak needle.4 cm of the tip was implanted in the vertebrae.The area around the pak needle was scraped with an airtome in order to remove it, and somehow about 2 cm was removed.However, there was no space where the screw could be inserted into the left pedicle of l5; the broken part remained in the vertebral body, so the screw could not be inserted; only the left side l4/s1 was fixated.There was a delay of more than 60 mins reported.There were no patient symptoms reported.There were no further complications reported regarding the event.
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Manufacturer Narrative
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Country: japan.Pma / 510(k) #: class i exempt.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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Manufacturer Narrative
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H3.Device evaluation summary: product analysis #283966158:part # pk1002 lot # be4320 visual and optical inspection confirmed the pak needle has broken.Optical inspection of the shaft did not reveal any damage to the instrument that could contribute to the break.This type of damage is consistent with bend stress 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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Search Alerts/Recalls
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