NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE PLATING SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Model Number LP4.5-MLT4B |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Deformity/ Disfigurement (2360)
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Event Date 03/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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A review of device history record for the plate confirmed no deviations in the manufacturing process and that the finished product met all required quality inspections prior to release.Should relevant additional information become available, a supplemental report will be filed.
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Event Description
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It was reported that in the early lengthening phase, it was discovered that the patient's tibia was developing a slight procurvatum deformity; however it was decided to continue with the lengthening process.It was also reported the plate had been implanted in an inverted orientation.The plate was removed after lengthening had reached an acceptable result and the surgeon made alignment adjustments and reinforced the surgical site with a static locking plate.Additionally, it was reported that during plate removal, one of the 4.5mm locking screws in the distal segment of the plate was noted to be broken and it was also discovered that the screw had been implanted with purchase in the near cortex only.Report 2 of 2.
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Event Description
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Additional information was received that a superficial wound infection was diagnosed.The infection is believed to be the result of prominent hardware in an area of limited soft tissue coverage.Additionally, the tension of the soft tissue over the plate increased and contributed to wound breakdown.
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Manufacturer Narrative
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Additional data.
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Search Alerts/Recalls
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