3.5 VA Locking Screw TRXV3.5-16 TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842188120688), received between Sep 18, 2020 and Sep 18, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 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.

• InjurySep 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A TRIMED SALES REP LOCATED IN THE UNITED STATES REPORTED ON (B)(6) 2020 THAT A SCREW (TRXV3.5-16 T) HAD STARTED BACKING OUT FROM THE PLATE AND BONE OF THE PATIENT. THE SCREW AND PLATE WAS ORIGINALLY IMPLANTED ON (B)(6) 2020, THE HEALING TIME FOR THIS PLATE AND SCREW IS ABOUT 6 WEEKS TO COMPLETE FIXATION. IN (B)(6) THE PATIENT STARTED EXPERIENCING IRRITATION AT THE IMPLANT SITE AND WHERE THAT SCREW WAS PLACED. AN X-RAY WAS TAKEN OF THE IMPLANT AND IT WAS DETERMINED THAT ONE OF THE SCREWS STARTED TO BACK OUT. THE SCREW WAS THEN REMOVED ON (B)(6) 2020, THE REST OF THE PLATE AND SCREWS WERE LEFT IN THE PATIENT AS THEY WERE NOT CAUSING ANY ADDITIONAL HARM, AND THE REST OF THE CONSTRUCT WAS HOLDING UP. THE SURGEON NOTED THAT THE JOINT WAS FUSED AND FIXATION HAD BEEN ACHIEVED, AND STATED THE REMOVAL DID NOT CAUSE ANY ADDITIONAL HARM TO THE PATIENT. THE SCREW WAS RETURNED TO TRIMED TO AID IN THE INVESTIGATION OF THE DEVICE.

  Patient problems: Burning Sensation; Implant Pain

  MAUDE report 10557182 ↗