MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 6X45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 186731645 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Osteolysis (2377)
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Event Date 01/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Additional narrative: event year is reported as 2021; however exact date of asd development is unknown.Additional device product codes: kwq; mnh; kwp; mni.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) 2016, the patient underwent a primary posterior lumbar interbody fusion (plif) (l4-5) procedure.On (b)(6) 2021, it was reported that the patient had suffered from asd between l3-4.The patient was scheduled to undergo a revision procedure (l3-4 plif extension) on (b)(6) 2021.No further information is available.This report is for one (1) viper system cortical fix polyaxial screw 5.5 6 x 45mm.This is report 10 of 12 for complaint (b)(4).
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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) 2016, the patient underwent a primary posterior lumbar interbody fusion (plif) (l4-5) procedure.On (b)(6) 2021, it was reported that the patient had suffered from asd between l3-4.The patient was scheduled to undergo a revision procedure (l3-4 plif extension) on (b)(6) 2021.No further information is available.This report is for one (1) viper system cortical fix polyaxial screw 5.5 6 x 45mm.This is report 10 of 12 for complaint (b)(4).
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Manufacturer Narrative
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Additional narrative: event year is reported as 2021; however exact date of asd development is unknown.Additional device product codes: kwq; mnh; kwp; mni.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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Search Alerts/Recalls
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