SYNTHES GMBH T-PAL SPACER 10MM X 28MM 7MM HEIGHT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
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Catalog Number 08.812.007S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Osteolysis (2377)
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Event Type
Injury
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from japan reports an event as follows: it was reported that patient underwent a surgery on (b)(6) 2018.Patient underwent extended re-fusion surgery on (b)(6) 2023, due to adjacent intervertebral disorders.Transforaminal lumbar interbody fusion (tlif) was performed on l2/3 and extended.Posterior lumbar interbody fusion (plif) was performed on l1/2.It is confirmed l4/5 achieved osteosynthesis.This report is for a t-pal spacer 10mm x 28mm 7mm height.This is report 1 of 2 for (b)(4).Additional reports are captured under pc-001504472 and pc-001505128.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: device history record (dhr) review conducted: part # 08.812.007s lot # l153555 manufacturing site: werk hagendorf release to warehouse date : 26 oct 2016 expiration date:n/a supplier: n/a a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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