MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 7.0X35; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
|
Back to Search Results |
|
Catalog Number 199725735S |
Device Problem
Break (1069)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/01/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
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.D2b: additional product code: kwq;mnh;mni;osh.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.
|
|
Event Description
|
Device report from synthes reports an event in japan as follows: it was reported that this was an unknown surgery on (b)(6) 2022.After the surgery, the screw in question broke.It was removed on (b)(6) 2023.No further information is available.This report is for one (1) 5.5 exp verse can scr 7.0x35.This is report 1 of 1 for complaint (b)(4).
|
|
Manufacturer Narrative
|
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.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.
|
|
Event Description
|
Patient status/outcome: no symptoms, under surgeon`s follow up.
|
|
Search Alerts/Recalls
|
|
|