WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM RECONSTRUCTION PLATE 10 HOLES/118MM; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
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Model Number 245.00 |
Device Problem
Bent (1059)
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Patient Problems
Failure of Implant (1924); Non-union Bone Fracture (2369)
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Event Type
Injury
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Manufacturer Narrative
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Patient¿s weight is unknown.Additional device product code: kwp.Complainant device 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.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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It was reported that a revision procedure was performed for ors right clavicle because the patient had a bicycle accident and re-injured himself on the same site.There was non-union and the plate was bent.The original plate was removed and a new plate was inserted.There was no surgical delay.Patient outcome was stable.Surgery was completed successfully.This report is for one (1) 3.5mm reconstruction plate 10 holes/118mm.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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A device history record review was performed for the subject device: part number: 245.00 lot number: 4923725 part manufacture date: 28-jan-2005 manufacturing location: (b)(4) part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5mm reconstruction plate 10 holes/118mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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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