MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 10X80; ORTHOSIS, SPINAL PEDICLE FIXATION
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Model Number 186727080 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problems
Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/2021 |
Event Type
Injury
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Event Description
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Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that a patient underwent a spinal surgery on (b)(6), 2019.On an unknown postoperative date the two (2) pedicle screws broke in the first sacral vertebra.The broken screws were removed and the revision surgery was performed on (b)(6), 2021.No further information provided.This report is for one (1) mis ti cfx fen poly 10x80 this is report 2 of 2 for complaint (b)(4).
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.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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