MEDOS INTERNATIONAL SÃ RL CH CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION
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Model Number 199723645 |
Device Problem
Break (1069)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Event Description
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Device report from synthes reports an event in belgium as follows: it was reported that on (b)(6) 2023, an extraction of broken screws was performed.A ct and rx scan was performed after patient complaints, and it was noted that the screw was broken off just at the head level.The screw was initially placed on level l2 (right) when fixating a fracture on disc level l1 around four years ago.No further information is available.This report involves one expedium verse spine system fenestrated cortical fix polyaxial screw 5.5 6.0 x 45mm.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.Brand name: expedium verse spine system fenestrated cortical fix polyaxial screw 5.5 6.0 x 45mm.Additional device product codes: pml.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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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.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: 199723645.Lot number: 204788.The product was released on: 02/07/2018.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 6.0x45, p/n: 199723645, lot: 204788, was broken at the proximal portion of the shaft.The device was returned incomplete, no other problems identified.A dimensional inspection was not performed as it is not applicable to the complaint condition.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 6.0x45, p/n: 199723645, lot: 204788 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.
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