NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE PLATING SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Model Number LP4.5-PRF4B |
Device Problem
Corroded (1131)
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Patient Problems
Impaired Healing (2378); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
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Event Description
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Information was received that upon explant corrosion was discovered on the plate around the male/ female junction and select screw sites.The surgeon also reported delayed union of the regenerate.
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Manufacturer Narrative
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Device evaluation: upon return, visual inspection of the plate revealed the distraction rod of the plate had discoloration.Utilizing external assessments and standard corrosion test methods, investigation of similar devices has identified mechanically assisted crevice corrosion (macc) based on mechanical micro-movement within the anti-rotation junction of the device as the likely direct cause.In-vitro testing has shown an increased load on the telescopic junction of the device may contribute to macc.Device records review: review of the device history records indicated that the returned product was visually inspected, functionally tested, and passed all quality inspections prior to release.
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Event Description
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During routine removal of the plate after the lengthening goal had been achieved, corrosion was discovered on the plate used on the left tibia.The corrosion was noted around plate's male/female junction and select screw sites.At the time of the removal, it was also noted that there was a delayed union of the regenerate in the left tibia; however, no osteolysis was found.A low profile static locking plate was implanted to provide extended surgical site stability and preserve new bone length.No patient harm or adverse impact is associated with this event.
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