Model Number MS1-5590S |
Device Problem
Corroded (1131)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 what appears to possibly be corrosion or calcified tissue/blood was noted on the rod.No additional information has been provided at this time.
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Manufacturer Narrative
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Additional data: b5, h6, h10 the magec rod has not been returned for an in-person evaluation.This investigation has been conducted based on provided images of the rod after removal surgery.The image reveals the rod was partially distracted with some wear/score marks on the distraction rod.Visible evidence of discoloration (corrosion) was noted at the junction of the distraction rod and housing tube which confirmed the reported failure.The large amount of the visible material is seemingly inconsistent with the relatively mild debris of surface damage noted, indicating that the majority of this debris was biologic in origin and likely bone-like material.
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Event Description
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No additional information has been provided.
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Manufacturer Narrative
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Additional data: b5, b6, d4, e1, e2, e3, h4, h6, h10.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.
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Event Description
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Additional information has been provided.
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Manufacturer Narrative
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Device evaluation: the rod has been received for in-person evaluation.Visual inspection of the returned rod revealed the rod was partially distracted with score marks on the distraction rod which indicate the rod was extended approximately 16 mm.No biologic material can been seen on the distraction rod.Likely all of the possible biologic material such as blood, bone-like material and tissue which were visible on the provided image has been wiped clean.Review of the work order revealed that the rod was visually inspected and functionally tested prior to release and met all the required quality inspections.Based on this investigation no sign of corrosion was discovered.The reported failure was initially confirmed based on provided image, however, once the rod was physically returned discoloration was not present once the blood/material was cleaned off for investigation.
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Event Description
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No additional information has been provided.
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Search Alerts/Recalls
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