Precice CTL4.5-040-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517029874), received between Apr 22, 2021 and Oct 13, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2021Break; Break

  INFORMATION WAS RECEIVED THAT A BROKEN SCREW WAS EXTRACTED. NO PATIENT ADVERSE EVENT WAS REPORTED. REPORT 2 OF 2.

  Patient problems: Failure of Implant

  MAUDE report 12628480 ↗
• InjuryApr 22, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2021 TO ADDRESS LOOSE SCREWS. AS PER THE REPORTER, APPROXIMATELY TWO AND A HALF WEEKS POST-IMPLANTATION, IT WAS DISCOVERED THAT THE SCREWS IN THE PROXIMAL BONE SEGMENT HAD LOOSENED AND DISENGAGED THE PLATE. NO PATIENT ADVERSE EVENT WAS REPORTED. DURING THE REVISION, THE SCREWS WERE RE-TIGHTENED AND THE SCREW HOLES WERE BACK-FILLED WITH CEMENT TO PREVENT FUTURE SCREW BACK-OUT. POST REVISION, THE PATIENT HAS SUCCESSFULLY RESUMED LENGTHENING. REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712092 ↗