MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 5.0 X 35MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Model Number 199721535 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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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 (b)(6) as follows: it was reported the patient experienced a post-operative infection.This is report 12 of 13 for (b)(4).Additional impacted products are captured on related 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional product codes: osh, mnh, kwp, mni, kwq.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products therapy date (b)(6) 2022.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.H10: additional narrative: h3, h4, h6: part 199721535, lot 283178: a manufacturing record evaluation was performed for the finished device and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: july 16, 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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Search Alerts/Recalls
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