Model Number 101-9812 |
Device Problems
Defective Device (2588); 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 04/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that the physician made multiple attempts to correctly size and place the superion indirect decompression system during the implant procedure.Multiple superion indirect decompression systems were broken with the top of the spindle cap broken off.A new indirect decompression system (ids) kit and new superion indirect decompression system were used and the procedure was completed successfully.
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Manufacturer Narrative
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The returned spacer was analyzed and visual inspection revealed that the spindle cap was completely sheared off from the implant body due to excessive force.The damage to the implant was sufficient to prevent functional testing.The damage to the implant suggested that excessive force was used during the procedure.The damage to the implant indicates device issue was likely due to deployment against resistance (e.G., bone) and/or manipulation of the position of the device by gear shifting of the inserter.
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Event Description
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It was reported that the physician made multiple attempts to correctly size and place the superion indirect decompression system during the implant procedure.Multiple superion indirect decompression systems were broken with the top of the spindle cap broken off.A new indirect decompression system (ids) kit and new superion indirect decompression system were used and the procedure was completed successfully.
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Search Alerts/Recalls
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