Model Number 101-9812 |
Device Problems
Difficult to Open or Close (2921); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that the physician noted that the patient had thick bone while applying the sagittal wiggle during the implant procedure of the superion indirect decompression (id) spacer.The physician heard the spindle cap pop, and the id spacer would no longer deploy.The id spacer was replaced with a smaller device and successfully implanted.Imaging taken in the field confirmed proper placement of the device and patient did well post-operatively.
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Manufacturer Narrative
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Analysis of the returned superion indirect decompression (id) spacer revealed that the spindle cap was completely sheared off from the implant body in addition to a severe abrasion on the mating surface of the actuator and tool damage to the spindle.The damage to the implant indicates failure was likely due to deployment again resistance and/or manipulation of the position of the device by gear shifting of the inserter.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states to not force deployment or implant breakage or damage to bony structures may result.Therefore, boston scientific concludes the probable cause of the reported event was unintended use error caused or contributed to event.
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Event Description
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It was reported that the physician noted that the patient had thick bone while applying the sagittal wiggle during the implant procedure of the superion indirect decompression (id) spacer.The physician heard the spindle cap pop, and the id spacer would no longer deploy.The id spacer was replaced with a smaller device and successfully implanted.Imaging taken in the field confirmed proper placement of the device and patient did well post-operatively.
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Search Alerts/Recalls
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