MEDOS INTERNATIONAL SÃ RL CH VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 199721000 |
Device Problem
Break (1069)
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Patient Problems
Failure of Implant (1924); Spinal Column Injury (2081); No Code Available (3191)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Event occurred on an unknown date in 2018.Additional procode: kwp;kwq;mnh;mni;osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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 synthes reports an event in (b)(6) as follows: it was reported that the verse advanced screws broke in the vertebral body post-operation.There is no further information available.Concomitant device reported: verse correction key (part# 199721000 , lot# 206919, quantity 1).Verse correction key (part# 199721000 , lot# 196158, quantity 1).Verse correction key (part# 199721000 , lot# 190651, quantity 1).Verse correction key (part# 199721000 , lot# 190159, quantity 1).5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# 155845, quantity 1).5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# 184191, quantity 1).5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# 175103, quantity 1).5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# 184192, quantity 1).This report is for one (1) verse correction key.This is report 5 of 8 for (b)(4).
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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.H11: correct data: g4: awareness date reported on initial report as december 03, 2018 but should have been september 22, 2020.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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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.Visual inspection: the verse correction key (part #: 199721000, lot #: 190651) was received at us customer quality (cq).The visual inspection performed on the returned device did not reveal any damage.Device failure/defect identified? no dimensional inspection: drawing: dwg-887010007 rev b specifications: major diameter: measured: major diameter : conform device used: hand micrometer om521 document/specification review: the following drawings were reviewed dwg-887010006 rev e (current and manufactured to): expedium verse dual lock assembly dwg-887010007 rev b (current and manufactured to): expedium verse dual lock poly lock dwg-887010008 rev b (current and manufactured to): expedium verse dual lock rod lock no design issues or discrepancies were identified.Complaint confirmed? no investigation conclusion: this complaint is not confirmed as the complaint device, verse correction key (part #: 199721000, lot #: 190651) was inspected and there was no issue reported.No definitive root cause could be determined based on the information provided.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot the dhr of product code: 199721000 lot : 190651 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: april 3, 2018.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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