MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYSTM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0X50MM; ORTHOSIS, SPINAL PEDICLE FIXATION
|
Back to Search Results |
|
Model Number 199723650 |
Device Problem
Break (1069)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 09/01/2022 |
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.Additional narrative: additional procode: pml.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 switzerland reports an event as follows: it was reported that the patient had been treated for an unstable th 12 fracture with expedium verse at the heights of th11-lkw 2 with cemented screws.The operation was completed without difficulty or complications.During a postoperative follow-up check, it was found that both screws in lkw1 were broken near the head.As a result, a revision operation was performed on (b)(6) 2022 to remove the broken screws and renew the osteosynthesis.This report is for an expedium verse spine system fenestrated cortical fix polyaxial screw 5.5 6.0 x 50mm.This is report 1 of 2 for (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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
|
|
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.H10 additional narrative: a manufacturing record evaluation was performed for the finished device it was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.Product code: 199723650.Lot number: 335773.The product was released on: 14/02/2022.Qty:(b)(4).The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the 5.5 exp verse fen scr 6.0x50 was broken across the neck between the head and the shaft, all of the fragments were returned.The edges of the broken sections appear to be smoothed out, most likely due to constant friction between the fragments before removal.A dimensional inspection for the 5.5 exp verse fen scr 6.0x50 was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 5.5 exp verse fen scr 6.0x50 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|