Device report from synthes reports an event in japan as follows: it was reported that an unknown surgery for adolescent idiopathic scoliosis was completed on (b)(6) 2022.After the surgery, on (b)(6) 2023, an infection was confirmed on concave side.Revision surgery occurred on (b)(6) 2023.During the revision, the set screws on t2·3·4·5 on the left were removed.The rod where the set screws were removed were cut by the t-saw.The rods were removed.Four of the uniplanar screws (5.0 diameter 30mm long) on the left t2-t5 were removed.The affected area was washed.The hook was placed on t2 (wide blade/throat 10).Side-side connector installed at the upper end of t5.Titanium rod connection was performed between t2 and t5.The wound was closed.This report is for one expedium spine system uniplanar screw 5.5 x 5.0 x 30mm for pc-(b)(4).This complaint is linked to pc-(b)(4).
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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:
b3: unknown when infection occurred.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10 concomitant therapy date february 9, 2022.E1: initial reporter is j&j company representative.G4: device is not distributed in the united states, but is similar to device marketed in the usa.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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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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