MEDOS INTERNATIONAL SÃ RL CH VIPER MONO SCREW 6X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 186717645 |
Device Problem
Break (1069)
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Patient Problems
Failure of Implant (1924); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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Additional device product codes: osh, mnh, kwp, mni, kwq.Part of the screw remained in the patient¿s bone; device not considered explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019 the patient underwent a pps to treat the traumatic injury.On (b)(6) 2021 x-rays were taken which revealed that two (2) screws had broken off in the centrum.On (b)(6) 2021 the patient underwent a revision procedure.The fragments were left in the patient's body.Other implants were successfully explanted.No further information is available.This report is for one (1) viper mono screw 6x45mm ti.This is report 1 of 2 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.H10 additional narrative: h3, h6: a review of the receiving inspection (ri) for viper mono screw 6x45mm ti was conducted identifying that lot number rl261427 was released in a single batch.Batch1: lot qty of (b)(4) units were released on october 4, 2017 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Product was not returned.Based on the information available, it has been determined that no corrective and 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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Search Alerts/Recalls
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