Investigation summary: the returned spacer was analyzed.Visual inspection revealed stripped threads on the actuator.The implant deployed with excessive resistance due to the stripped threads.Device history record review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Labeling review: a product labeling review identified that the device was used per the directions for use (dfu) / product label.: additionally, it was confirmed that the ifu addresses the caution as it lists 'damage to nerve roots to the spinal cord causing partial or complete sensory or motor loss' is noted within the dfu as a potential complication associated with the use of the device.Investigation conclusion: the complaint regarding the patient's apraxia was confirmed, the probable cause is known inherent risk of device.Analysis of the device found stripped threads on the actuator, which caused the spacer to deploy with excessive resistance.The probable cause of the damage is unintended use error caused or contributed to event.The damage to the spacer suggest that the user exerted excessive force while attempting to deploy or remove the device.
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