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Model Number G9010001601 |
Device Problems
Migration or Expulsion of Device (1395); Malposition of Device (2616)
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Patient Problems
Patient Problem/Medical Problem (2688); Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Pma/510k: this part is not approved for market in the us.However a like device with part# 8293420, 510k# k031967 and upn# (b)(4) is marketed in the us.Neither the device nor films of applicable imaging studies were 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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Pre op diagnosis: false joint occurred post op, set screw came off and false joint occurred.The patient had difficulty in both standing and sitting for a long time.
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Manufacturer Narrative
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H3: product analysis: g9010001601; lot# 0718269w.After visual and optical examination and functional testing, it does not appear to be any damage nor does it indicate any functional issues with the screw.There was no fault found.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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Patient demographics: gender- male, age- 60 years pre op diagnosis: false joint occurred implant date: (b)(6) 2019.Explant date: (b)(6) 2020.(planned) initial surgery details: procedure performed: posterior lumbar interbody fusion (plif) at l5/s in 2011 and posterior lumbar interbody fusion (plif) at l3/4 in 2019 and posterior lumbar fusion (plf) was performed at l4/5 on (b)(6) 2019 it was reported that post op, products backed out and malpositioned.The connector backed out after final tightening.Final tightening of the set screw came off and false joint occurred.The patient had difficulty in both standing and sitting for a long time.The connector of tsrh rp2 had come off at multiple places, but the cause was not mentioned.In the report, four connectors were reported, but it was unclear if they all had come off.A re-operation was performed on (b)(6) 2020.
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Search Alerts/Recalls
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