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Catalog Number 497.125 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Patient information is not available for reporting.Date of postoperative device breakage is unknown.Unknown if the device was implanted during (b)(6) 2014 surgery or during (b)(6) 2017 surgery.Therapy date is either (b)(6) 2014 or (b)(6) 2017.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2014, the surgery for infant scoliosis was performed to fix the thoracolumbar by using the vertical expandable prosthetic titanium rib (vepter) system.Following continuous extension surgeries, a full extension surgery was performed on (b)(6) 2017.Around (b)(6) 2018, it was confirmed under the x-ray that the extension bar and rod had come off due to the possibility of the closure being detached.On (b)(6) 2018, during the planned revision surgery, part of these implants was confirmed to have been broken when extracted.The breakage occurred before the revision surgery.All the implants as well as the broken part were extracted and the revision surgery was successfully completed.There was no adverse consequence to the patient.Concomitant devices reported: ti rib sleeve-size 8 220mm radius (part # 497.107, lot # 7002855, quantity 1); ti lumbar extension size 8/220mm radius (part # 497.133, lot # 6032046, quantity 1); ti distraction lock (part # 497.125, lot # h243898, quantity 1).This report is for one (1) ti distraction lock.This is report 2 of 2 for complaint (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.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.H10 additional narrative: h11 corrected data: d10: date device returned to manufacturer.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.Number of parts in complaint: ti rib sleeve-size 8 220mm radius (part # 497.107, lot # 7002855, quantity 1) is no longer considered to be concomitant.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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This is report 2 of 3 for complaint (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.H10 additional narrative: h3, h4, h6: dhr review was completed.Brandywine dhr review part no.: 497.125.Lot no.: 6976761.Manufacturing location: brandywine.Supplier: rms.Expiration: non-sterile.Release to warehouse date: 16-jul-2012.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Dhr review of raw material revealed this lot met all specification with no nonconformities noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product h3, h6: customer quality conducted an investigation of the returned device.Us customer quality (cq) investigation workflow: broken visual inspection: visual inspection performed at customer quality of the returned distraction lock revealed the device was not broken.No major damage or deformation was observed.Minor nicks were observed that are consistent with implantation/explantation.Based on visual inspection, the condition of the device does not agree with the reported complaint description - the complaint condition was not confirmed, and no other failures were detected.Dimensional inspection: dimensional inspection of the distraction lock was not conducted as the complaint condition was not confirmed, and no other failures were detected.Document/specification review: device history record(s) showed that there were no issues during the manufacture of this product including the materials and its properties, which would contribute to this complaint condition.A relevant drawing review for the returned device was not performed as the complaint condition was not confirmed, and no other failures were detected.Conclusion: the complaint condition of the broken distraction lock was not confirmed; no malfunctions of the device were detected.There is no indication of a design or manufacturing defect as a result of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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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