FDA 483 - Life Spine, LLC. - May 02, 2025
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Life Spine, LLC. in Huntley, IL, received a Form FDA 483 for deficiencies in its medical device reporting and complaint handling processes. The firm failed to submit a Medical Device Report (MDR) within 30 days for a Prolift device malfunction that caused a surgical delay and required intervention. Additionally, investigation records for MDR reportable complaints were found to have inadequate information, including improperly answered questions and miscategorized events.
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