ProAxis Spinal Surgery Table (int'l) 6988IRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842430106880), received between Feb 21, 2019 and Feb 21, 2019 — classified as 5 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS POSITIONED PRONE FOR T4-PELVIS FUSION UTILISING THE STANDARD PROAXIS SPINE ASSEMBLY (OPEN FRAME/SPARS) CONFIGURED WITH TORSO TROLLEY, ARM BOARDS, CHEST/PELVIC BOLSTERS AND LEG SUPPORT. ALL ITEMS WERE COVERED PRIOR TO THE PROCEDURE WITH THE RECOMMENDED OSI SHEAR PROTECT CONSUMABLES TO MINIMISE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH PRESSURE RELATED SORES IN THE FOLLOWING AREAS - EYELIDS, CHIN, LEFT PRECORDIAL REGION, RIGHT ILIAC CREST (LEFT AND RIGHT HIPS). THE LEFT AND RIGHT HANDS/WRIST ALSO HAD SOME SWELLING AND BLISTERING AND THE RIGHT CALF SUSTAINED A GRADE 2 TEAR. IT WAS NOTED THAT BMI AND LENGTH OF CASE (UP TO 14 HOURS) COULD HAVE BEEN CONTRIBUTING FACTORS.

  Patient problems: Pressure Sore/Ulcer; Skin Tears; Swelling

  MAUDE report 8358172 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS POSITIONED PRONE FOR L3-S1 PLIF UTILISING THE STANDARD PROAXIS SPINE ASSEMBLY (OPEN FRAME/SPARS) CONFIGURED WITH TORSO TROLLEY, ARM BOARDS, CHEST/PELVIC BOLSTERS AND LEG SUPPORT. ALL ITEMS WERE COVERED PRIOR TO THE PROCEDURE WITH THE RECOMMENDED OSI SHEAR PROTECT CONSUMABLES TO MINIMISE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH PRESSURE RELATED SORES IN THE FOLLOWING AREAS - TENDERNESS/REDNESS ON CHEST (AS WELL AS SMALL SKIN TEAR RIGHT SIDE) AND FOREHEAD. GRADED AS MINOR, SURGERY DURATION WAS 8 HOURS.

  Patient problems: Erythema; Pain; Pressure Sore/Ulcer; Skin Tears

  MAUDE report 8358095 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS POSITIONED PRONE FOR POSTERIOR SCREW FIXATION UTILISING THE STANDARD PROAXIS SPINE ASSEMBLY (OPEN FRAME/SPARS) CONFIGURED WITH TORSO TROLLEY, ARM BOARDS, CHEST/PELVIC BOLSTERS AND LEG SUPPORT. ALL ITEMS WERE COVERED PRIOR TO THE PROCEDURE WITH THE RECOMMENDED OSI SHEAR PROTECT CONSUMABLES TO MINIMISE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH PRESSURE RELATED SORES IN THE FOLLOWING AREAS - CENTRE OF CHEST/STERNUM AND RIGHT FLANK/ABDOMEN (SMALL TO LARGE BLISTERS). SEVERITY RECORDED AS MINOR, CASE LENGTH WAS 4 HOURS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 8357883 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS POSITIONED PRONE FOR L4/L5 L5/S1 POSTERIOR LUMBAR INTERBODY FUSION UTILISING THE STANDARD PROAXIS SPINE ASSEMBLY (OPEN FRAME/SPARS) CONFIGURED WITH TORSO TROLLEY, ARM BOARDS, CHEST/PELVIC BOLSTERS AND LEG SUPPORT. ALL ITEMS WERE COVERED PRIOR TO THE PROCEDURE WITH THE RECOMMENDED OSI SHEAR PROTECT CONSUMABLES TO MINIMISE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH A GRADE 1 PRESSURE SORE ACROSS AREAS OF THE CHEST AND LEFT SIDE GROIN. SEVERITY WAS MINOR. LENGTH OF CASE (UP TO 8 HOURS) COULD HAVE BEEN A CONTRIBUTING FACTOR.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 8357807 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS POSITIONED PRONE FOR SCOLIOSIS CORRECTION UTILISING THE STANDARD PROAXIS SPINE ASSEMBLY (OPEN FRAME/SPARS) CONFIGURED WITH TORSO TROLLEY, ARM BOARDS, CHEST/PELVIC BOLSTERS AND LEG SUPPORT. ALL ITEMS WERE COVERED PRIOR TO THE PROCEDURE WITH THE RECOMMENDED OSI SHEAR PROTECT CONSUMABLES TO MINIMISE RISK OF SKIN INJURY. POSTOPERATIVELY, THE CLIENT PRESENTED WITH REDNESS/SORE TO LEFT SIDE OF ARM. SEVERITY WAS MINOR. LENGTH OF CASE (UP TO 13 HOURS) COULD HAVE BEEN CONTRIBUTING FACTOR.

  Patient problems: Erythema; Pressure Sore/Ulcer

  MAUDE report 8357765 ↗