MEDOS INTERNATIONAL SÃ RL CH UNK - SCREWS: EXPEDIUM VERSE; ORTHOSIS, SPINAL PEDICLE FIXATION
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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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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.D1, d2a, d2b, d3, d4, g4 - 510k: this report is for an unknown screws: expedium verse/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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 japan as follows: it was reported that this was a 3a3b fusion for a fracture of t12 on (b)(6) 2023.In the surgery, cement was used at t9 and l3.The patient had a crooked spine, so the rods were placed flatter than usual to realign it.After surgery, a dilation fracture of the anterior vertebral body (l1) and infection occurred.On (b)(6) 2023, a revision surgery was performed due to the symptoms.In the revision surgery, the infected layer was detached.The revision surgery was completed successfully with no surgical delay.No further information is available.This report is for one (1) unk - screws: expedium verse.This is report 2 of 3 for complaint.
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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: e1 additional reporter reported 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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