Alignment Software Spine 2.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056481144470), received between Sep 6, 2023 and Jun 20, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• InjuryJun 20, 2025Use of Device Problem; Use of Device Problem

  A MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE FOR A FUSION OF VERTEBRAE L4 TO L5, DUE TO SPINAL STENOSIS, WITH INTENDED PLACEMENT OF 4 SPINE SCREWS BILATERAL FOR FIXATION, WAS PERFORMED WITH THE AID OF THE BRAINLAB ALIGNMENT SOFTWARE SPINE 2.0. FROM AN INTRA-OPERATIVE CT SCAN, THE SURGEON DETERMINED THAT OF 2 OF 4 SCREWS PLACED, THE RIGHT SIDED L4 AND L5 SCREWS, DEVIATED SHIFTED BY CA. 10MM FROM THEIR INTENDED POSITIONS. THE DEVIATING SCREWS WERE REMOVED AND THEIR PLACEMENT CORRECTED WITH NAVIGATION AT THE VERY SAME SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED, WITH ALL PLACEMENTS CORRECT AT THE END OF THE SURGERY. - THERE WAS NO DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO DEVIATING PLACEMENTS. - THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT RESULTING, AND THERE WAS ALSO NO NEGATIVE EFFECT DUE TO THE SURGERY/ANESTHESIA PROLONGATION OF CA. 30MIN. - THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS ALSO NOT PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297380 ↗
• InjurySep 6, 2023Use of Device Problem; Use of Device Problem

  AN OPEN INVASIVE SURGERY (ON (B)(6) 2023) ON THE THORACIC AND LUMBOSACRAL SPINE FOR A POSTERIOR FUSION OF VERTEBRAE T4 TO S2, WITH SCOLIOSIS PEAKING AT L3, WITH INTENDED PLACEMENT OF 31 K-WIRES (AND 27 SCREW PLACEMENTS FOLLOWING THE K-WIRES, AND KYPHOPLASTY AT TWO LEVELS), WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE ALIGNMENT SOFTWARE SPINE 2.0. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE SPINOUS PROCESS OF T12. FOR LEVELS T4 TO T12, ACQUIRED AN INTRA-OPERATIVE CT SCAN WITH AUTOMATIC IMAGE REGISTRATION OF THE CURRENT PATIENT ANATOMY TO THE NAVIGATION, AND VERIFIED AND ACCEPTED THE ACCURACY TO PROCEED. PLANNED TRAJECTORIES FOR THE SCREW PLACEMENTS. PLACED K-WIRES AND SCREWS STARTING AT T4 LEVEL AND WORKING TO T12 LEVEL, ALTERNATING BETWEEN LEFT AND RIGHT (AT LEVELS T4 AND T5 PLACED K-WIRES ONLY, NO SCREWS, SINCE KYPHOPLASTY TO BE PERFORMED AT THESE LEVELS). FOR EACH K-WIRE/SCREW: ALIGNED THE CIRQ ROBOTIC ARM TO THE PLANNED TRAJECTORY LOCATION USING THE ALIGNMENT SW, INSERTED THE NAVIGATED 3.2MM DRILL GUIDE TUBE THROUGH THE CIRQ ROBOTIC ARM, MALLETED THE GUIDE TUBE INTO THE PEDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17689418 ↗