DEPUY SPINE INC EXP TI POLY SCREW 7.5MMX30MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Model Number 179712030 |
Device Problem
Break (1069)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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Additional procode: kwp; kwq; mnh; mni; osh.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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was allegedly reported by the patient's legal counsel that on (b)(6) 2017, a transpedicular screw that was used for spine stabilization has broken causing unspecified injuries which required medical intervention.There is no further information available.Concomitant device reported: unknown rod(part# unknown, lot# unknown, quantity# unknown).Unknown set screw(part# unknown, lot# unknown, quantity# unknown).This report is for one (1) exp ti poly screw 7.5mmx30mm.This is report 1 of 1 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.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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