MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 X 35MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number 186731435 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pressure Sores (2326)
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Event Type
Injury
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Event Description
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Device report from synthes reports an event in japan as follows: it was reported that a psf (posterior spinal fusion) at t9-l1 was performed on (b)(6) 2014.After surgery, a pressure ulcer was observed at the upper end of t9.Ic was held between the surgeon and the patient to confirm whether to remove only the rod at the affected site, or to remove all the implants.It was decided to remove all implants.The removal surgery was performed on (b)(6) 2023.Bone union is complete.All implants were removed without any problems, and the removal surgery was completed successfully.This report involves one viper system cortical fix polyaxial screw 5.5 4.35 x 35mm.This is report 2 of 10 for (b)(4).This report is related to (b)(4), which captures additional impacted products.
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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.D2b: additional device product codes: mnh, kwp, kwq, mni.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10: additional concomitants captured on related complaint, (b)(4).E3: reporter is a j&j employee.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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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.H3, h4, h6: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.Device history review (dhr): a review of the receiving inspection (ri) for 5.5 ti cort fix 4.35x35mm, was conducted identifying that lot number tbfwy was released in one batch; batch1: lot qty of (b)(4) units were released on jul 24, 2013 with no discrepancies.Supplier: depuy: tomz corp.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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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