LOTUS 32545-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840606106917), received between Mar 26, 2024 and Aug 6, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2024Fracture; Mechanical Problem; Fracture; Mechanical Problem

  RECEIVED REPORT FROM PATIENT. PATIENT STATES HE UNDERWENT 6 LEVEL POSTERIOR CERVICAL THORACIC FIXATION SURGERY AT C2-T1 ON (B)(6) 2019. PATIENT STATES HE WAS CLEARED FOR NORMAL ACTIVITY. REPORTEDLY T1 HAD NOT FUSED AND THE T1 SCREW FRACTURED 3 YEARS POST-OP. THE DEVICE WAS REMOVED/REVISED ON (B)(6) 2023. ON (B)(6) 2023 SURGEON ATTEMPTED A FUSION SURGERY AGAIN T1-T2. AND MOST RECENTLY THE CONSTRUCT WAS EXTENDED FOUR LEVELS FROM T2-T6. PATIENT STATES HE IS CURRENTLY DOING WELL BUT ENDURED PAIN.

  Patient problems: Failure of Implant

  MAUDE report 19920140 ↗
• MalfunctionMar 26, 2024Fracture; Mechanical Problem; Fracture; Mechanical Problem

  PATIENT UNDERWENT PCF SPINAL FUSION SURGERY AT C2-T2 ON (B)(6) 2023. ON (B)(6) 2024 IT WAS REPORTED THAT THE RIGHT T2 BONE SCREW WAS FRACTURED. THERE IS NO PLAN TO REVISE THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 18980376 ↗