OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE 16MM STERILE; PLATE,FIXATION,BONE
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Catalog Number 401.766TS |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Device history lot reviewed part: 401.766ts.Lot: 6l29744.Manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: oct 14, 2019.Expiry date: sep 01, 2024.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part number: 401.766.Lot number: 5l76981.Manufacturing site: (b)(4).Release to warehouse date: aug 19, 2019.A manufacturing record evaluation was performed for the non-sterile device lot number, and no non-conformances were identified.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient was treated for a secondary disassociated distal radius extension fracture due to fracture wasn't fixated as planned.It is unknown how the issue was discovered.It is unknown if there was a patient consequence.This complaint involves ten (10) devices.This report is for (1)2.4mm ti cortex screw slf-tpng with t8 stardrive 16mm sterile.This is report 2 of 10 for (b)(4).Related product complaint: (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.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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Update: no additional revision surgery was performed due to the event.
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Event Description
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Update: the initial surgery occurred (b)(6) 2020.
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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.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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Product complaint #(b)(4).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: b4: alert date should be 8/13/2020, not 9/14/2020.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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