VariAx 656320SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327070712), received between Nov 13, 2020 and Jul 28, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (7 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "THREE LOCKING SCREWS FAILED TO LOCK DURING SURGERY FOR DISTAL END OF THE LEFT RADIUS USING VARIAX DR. THE LOCKING SCREWS DID NOT LOCK ONTO THE PLATE AND SPUN WITHOUT FASTENING. ALL THREE SCREWS WERE REPLACED WITH NEW SCREWS. AFTER REPLACEMENT, THE PLATE COULD BE LOCKED USING NEW SCREWS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414076 ↗
• MalfunctionJul 28, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "THREE LOCKING SCREWS FAILED TO LOCK DURING SURGERY FOR DISTAL END OF THE LEFT RADIUS USING VARIAX DR. THE LOCKING SCREWS DID NOT LOCK ONTO THE PLATE AND SPUN WITHOUT FASTENING. ALL THREE SCREWS WERE REPLACED WITH NEW SCREWS. AFTER REPLACEMENT, THE PLATE COULD BE LOCKED USING NEW SCREWS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414075 ↗
• MalfunctionFeb 17, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "THE LOCKING SCREW DID NOT LOCK TO THE VARIAX DR PLATE. NO SCREW WAS USED FOR THAT SCREW HOLE (THE MOST DISTAL, SECOND SCREW HOLE FROM ULNAR SIDE)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16400509 ↗
• MalfunctionDec 16, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN SCREWING IN A 2.7 DR SCREW, IT DID NOT BLOCK AND COULD BE TURNED. REPLACEMENT WAS AVAILABLE." ADDITIONAL INFORMATION: "YES, IT HAS BEEN PRE-DRILLED. THE BONE QUALITY WAS VERY POOR." SURGICAL DELAY OF 2 MINUTES NOT LONGER. NO OTHER CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11024036 ↗
• MalfunctionDec 16, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN SCREWING IN A 2.7 DR SCREW, IT DID NOT BLOCK AND COULD BE TURNED. REPLACEMENT WAS AVAILABLE." ADDITIONAL INFORMATION: "YES, IT HAS BEEN PRE-DRILLED. THE BONE QUALITY WAS VERY POOR." SURGICAL DELAY OF 2 MINUTES NOT LONGER. NO OTHER CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023903 ↗
• MalfunctionDec 16, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN SCREWING IN A 2.7 DR SCREW, IT DID NOT BLOCK AND COULD BE TURNED. REPLACEMENT WAS AVAILABLE." ADDITIONAL INFORMATION: "YES, IT HAS BEEN PRE-DRILLED. THE BONE QUALITY WAS VERY POOR." SURGICAL DELAY OF 2 MINUTES NOT LONGER. NO OTHER CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023814 ↗
• MalfunctionDec 16, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN SCREWING IN A 2.7 DR SCREW, IT DID NOT BLOCK AND COULD BE TURNED. REPLACEMENT WAS AVAILABLE." ADDITIONAL INFORMATION: "YES, IT HAS BEEN PRE-DRILLED. THE BONE QUALITY WAS VERY POOR." SURGICAL DELAY OF 2 MINUTES NOT LONGER. NO OTHER CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023758 ↗
• MalfunctionNov 13, 2020Failure to Align; Failure to Align

  AS REPORTED: "I INSERTED THE LOCKING SCREW INTO THE PLATE IN A PROPER WAY, BUT IT DID NOT LOCK. I REPLACED IT WITH ANOTHER SCREW OF THE SAME SIZE AND IT LOCKED WITHOUT ANY PROBLEMS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10840390 ↗