BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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Model Number 101-9814 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an indirect decompression implant procedure, while deploying the 14mm device, the physician noted moderate resistance.When the physician continued to deploy the device, there was a popping sound and the metal ring on the top of the implant popped off.The broken implant was retrieved from the patient.A new 12mm implant was loaded and deployed successfully with no further issue.
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Event Description
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It was reported that during an indirect decompression implant procedure, while deploying the 14mm device, the physician noted moderate resistance.When the physician continued to deploy the device, there was a popping sound and the metal ring on the top of the implant popped off.The broken implant was retrieved from the patient.A new 12mm implant was loaded and deployed successfully with no further issue.Additional information was received that the physician did not use excessive force during the procedure.It was noted there seemed to be a thick lamina on the level above causing resistance.The physician did gearshift the inserter during the procedure, however the implant broke as he was trying to deploy it.The implant was properly connected to the inserter during the procedure.
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Event Description
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It was reported that during an indirect decompression implant procedure, while deploying the 14mm device, the physician noted moderate resistance.When the physician continued to deploy the device, there was a popping sound and the metal ring on the top of the implant popped off.The broken implant was retrieved from the patient.A new 12mm implant was loaded and deployed successfully with no further issue.Additional information was received that the physician did not use excessive force during the procedure.It was noted there seemed to be a thick lamina on the level above causing resistance.The physician did gearshift the inserter during the procedure, however the implant broke as he was trying to deploy it.The implant was properly connected to the inserter during the procedure.
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Manufacturer Narrative
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101-9814, lot 40045657.The investigation concluded that the complaint of the metal ring on the top of the implant popped off was confirmed.Upon visual examination, the returned implant revealed that the spindle cap was completely sheared off from the implant body and actuator shaft, and that the spindle found to be outside of the main body of the implant.The damage to the implant was sufficient to prevent functional testing, and indicates failure 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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