MEDOS INTERNATIONAL SÃ RL CH DUAL DIAMETER ROD 3.5X5.5, 600; POSTERIOR CERVICAL SCREW SYSTEM
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Catalog Number 188311012 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2024 |
Event Type
malfunction
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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: d2b: additional product code: kwp, mni 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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It was reported that spinal rod broke four years post-op, patient has manual labor job (construction) and heard loud pop when picking up tool bag, no immediate pain but followed up with clinician and it was found that rod had broken.Patient is fully healed, no pain or discomfort in the area, no fragment generation, all other implants (pedicle screws) appear to be in tact.There was posterior cervicothoracic fusion, c6 to t10.Initial implantation occurred in 2020.Patient had a ct scan last week to confirm no additional hardware breakage, which was confirmed.Only the single rod failed.Patient has no pain or indications for removal, therefore the implants remain in the patient with no anticipation of removal.There was no patient outcome.This report is for one (1) dual diameter rod 3.5x5.5, 600 this is report 1 of 1 for complaint (b)(4).
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Search Alerts/Recalls
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