# FDA 483 - Life Spine, LLC. - May 02, 2025

Source: https://www.keypedia.com/records/483/life-spine-llc/f6845456-4a95-4329-8376-1c39f851cfff

> FDA 483 for Life Spine, LLC. on May 02, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Life Spine, LLC.
- Inspection Date: 2025-05-02
- Product Type: device
- Office Name: Chicago District Office
- Summary: 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.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.keypedia.com/companies/life-spine-llc/721d7601-db85-41c2-a384-99ee2f1e7bad

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669