Precice CTL4.5-022-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517029980), received between Mar 30, 2021 and Mar 30, 2021 — classified as 1 injury.

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

• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT IN THE EARLY LENGTHENING PHASE, IT WAS DISCOVERED THAT THE PATIENT'S TIBIA WAS DEVELOPING A SLIGHT PROCURVATUM DEFORMITY; HOWEVER IT WAS DECIDED TO CONTINUE WITH THE LENGTHENING PROCESS. DURING REMOVAL OF THE PLATE AFTER LENGTHENING HAD REACHED AN ACCEPTABLE RESULT, ONE OF THE 4.5MM LOCKING SCREWS IN THE DISTAL SEGMENT OF THE PLATE WAS NOTED TO BE BROKEN AND IT WAS ALSO DISCOVERED THAT THE SCREW HAD BEEN IMPLANTED WITH PURCHASE IN THE NEAR CORTEX ONLY. ADDITIONALLY, IT WAS REPORTED THE PLATE HAD BEEN IMPLANTED IN AN INVERTED ORIENTATION. THE SURGEON MADE ALIGNMENT ADJUSTMENTS AND REINFORCED THE SURGICAL SITE WITH A STATIC LOCKING PLATE. REPORT 1 OF 2.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11589047 ↗