EVOS 71158104Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556693827), received between Dec 30, 2019 and Nov 30, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A DISTAL RADIUS OPERATION, TWO DISTAL SCREW HOLES DIDN´T WORK PROPERLY WAY, AS THE LOCKING SCREWS DIDN´T LOCKED INTO TWO OF THE DISTAL HOLES ON THE RIGHT SIDE OF THE EVOS VOLAR PLATE 4H LEFT STD STD TI 56MM. THE EVOS VOLAR PLATE 4H LEFT STD STD TI 56MM WAS INSPECTED AND IT WAS NOTICED THAT THOSE TWO HOLES WERE DAMAGED. SURGERY WAS RESUMED WITH A BACK-UP PLATE, AFTER A SIGNIFICANT DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237747 ↗
• MalfunctionNov 14, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, TWO LOCKING SCREWS WENT THROUGH THE DISTAL HOLES OF THE EVOS VOLAR PLATE 4H LEFT STD, STD TI 56MM DEVICE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15787668 ↗
• InjuryApr 21, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN INSERTING AN SCREW THROUGH THE PLATE, THE HEAD WENT STRAIGHT THROUGH THE PLATE AND DID NOT ENGAGE WITH THE LOCKING PETALS. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. THE PLATE AND SCREW WAS REMOVED BEFORE AN ADDITIONAL BONE HOLE WAS MADE IN ORDER TO CORRECTLY FIXATE THE SAME PLATE AGAIN. THE SCREW WAS EXPLANTED AND DISCARDED.

  Patient problems: Rupture

  MAUDE report 14165533 ↗
• MalfunctionDec 30, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY AN EVOS WRIST TI 4H STD L VOLAR DISTAL RADIUS PLATE (71158104) WAS USED WITH A 16MM LOCKING SCREW (74412416), BUT THE SCREW FELL THROUGH THE PLATE. THEN, AN EVOS WRIST TI 3H STD L VOLAR DISTAL RADIUS (PLATE 71158103) WITH A NEW 16MM SCREW (74412416) WAS TRIED AND IT HAD THE SAME ISSUE. THE SURGERY WAS COMPLETED USING AN OLD-STYLE VOLAR DISTAL RADIUS SET. ADDITIONALLY, 11MM CORTEX SCREW (74402411) WAS FOUND TO HAVE THE SAME FAILURE AS WELL. FOR THIS EVENT, THERE WAS A DELAY GREATER THAN 30 MIN AND THE PATIENT WAS NOT INJURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9532182 ↗