MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 6.0X40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Catalog Number 199725640S |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
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: d4: lot # is either 219213, 224775, or 328933.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes 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 japan reports an event as follows: it was reported that on (b)(6) 2022, a posterior lumbar interbody fusion (l3/4) was performed.The procedure was completed successfully with no surgical delay.On (b)(6) 2024 a revision procedure was performed for an unknown cause.L3/4 plif had bony fusion.During the surgery, the sfx unitized set screw and rod were removed.When the l3 left screw in question was removed, it was found to have broken just below the screw head.The l3 right side screw was then removed, a cage was installed between l4/5, a screw was inserted at l5, and a rod, unitized set screw and sfx were installed.The distal screws from the screw head of the broken screw were retained in the body.There are no broken pieces in the patient, which was confirmed by x-ray.The surgery was completed successfully with no surgical delay.The patient outcome is stable.No further information is available.This report is for a 5.5 exp verse can scr 6.0x40.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5.D4: lot.H3, h4, h6: a manufacturing record evaluation was performed for the finished device.Product code: 199725640s.Product name: 5.5 exp verse can scr 6.0x40.Lot number: 328933.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 08-dec-2021.Manufacturing site:jabil le locle.Expiry date:31-oct-2026.The product was not returned to depuy synthes, however photos were provided for review.The x-ray investigation revealed that threaded shaft of the screw is observed remained in patient body, as per surgeon decision; forcing the extraction may lead to patient harm.Head of the screw is not observed, indicating breakage of the device.Potential cause of this situation cannot be fully established, factors such as age of the patient, underlying disease, bone density, or a possible early weight-bearing, can lead to failure of the implant.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 5.5 exp verse can scr 6.0x40 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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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The patient is reported as stable.
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Search Alerts/Recalls
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