Model Number RA002-4545SL |
Device Problems
Mechanical Problem (1384); Structural Problem (2506); Physical Resistance/Sticking (4012)
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Patient Problem
Failure of Implant (1924)
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Event Date 07/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for investigation nor were xrays or pictures provided to confirm the alleged event.Root cause is unknown at this time.
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Event Description
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Information was received that a revision procedure was performed on (b)(6) 2020 for definitive fusion as the rods hadn't distracted much over the last 12 months.
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Manufacturer Narrative
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Additional data: b5, b6, g2, h4, h6, h10 corrected data: g4 evaluation was performed by newcastle engineering lab.The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
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Event Description
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The device was sent to newcastle university engineering lab for evaluation who reported that during examination the radial bearing could rotate but it was seized to the magnet.No further disassembly was possible, therefore, the drive pin was unable to be examined.The o-ring seal was intact, however, it was thinner in one region.Consequently, it was likely unable to seal effectively.
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Search Alerts/Recalls
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