VariAx 52-23620Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 37613153067994), received between Jan 25, 2021 and Jan 25, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2021Positioning Failure; Positioning Failure

  AS REPORTED: ON (B)(6) 2020, THE PATIENT FELL DOWN ON A BICYCLE WHICH LEAD TO RIGHT WRIST SUFFERED STRESS, AND IMMEDIATELY THE DISTAL END OF THE RIGHT FOREARM WAS DEFORMED AND THE PAIN WAS SEVERE. ACCORDING TO CT INSPECTION, THE PATIENT WAS DIAGNOSED RIGHT DISTAL RADIUS FRACTURE AND ULNAR STYLOID FRACTURE BY THE SECOND HOSPITAL OF HAI SHU DISTRICT. ON (B)(6) 2020, PATIENT CAME TO THE SIXTH OF (B)(6) HOSPITAL, AND REQUESTED SURGERY FOR FURTHER TREATMENT. THE PATIENT WAS DIAGNOSED TWO ISSUES BY THE SIXTH OF (B)(6) HOSPITAL. ONE IS RIGHT DISTAL RADIUS FRACTURE AND ULNAR STYLOID FRACTURE. THE OTHER ONE IS DIABETES. ON (B)(6) 2020, PATIENT WAS PERFORMED REDUCTION INTERNAL FIXATION SURGERY UNDER INTRAVENOUS ANESTHESIA AND NERVE BLOCK DESCENDING. DURING MEDICAL OPERATION, WHEN THE NINE CROSS-HEAD LOCKING SCREWS WERE SCREWED IN, ONE OF SCREWS(PART NUMBER 52-23620S ) WAS SLIPPED. IT CAN¿T BE SCREW INTO PLATE. THE SURGEON FELT THAT THE SCREW THREAD OF THIS SCREW WAS NOT MATCH WITH PLATE. A SAME SPECIFICATION AND LOT REPLACEMENT WAS USED TO SCREW IN PLATE. SURGEON USED THE SAME HOLE ON THE PLATE WITH ANOTHER SCREW SUCCESSFULLY. C-ARM FLUOROSCOPY SHOWED THAT THE BROKEN PART WAS IN GOOD ALIGNME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11225500 ↗