PRECICE® STRYDE System PS10.0-65B250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517950758), received between Aug 5, 2024 and Aug 5, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Corroded” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Oct 29, 2021Open, Classified

   The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

   Z-0319-2022 · Root cause: Device Design · Recall details · FDA record ↗

2. Feb 12, 2021Open, Classified

   Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

   Z-1323-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionAug 5, 2024Corroded; Material Discolored; Physical Resistance/Sticking; Corroded; Material Discolored; Physical Resistance/Sticking

  AN INVESTIGATION REPORT FROM AN IMPLANT RETRIEVAL CENTER WAS RECEIVED, DETAILING THE EXAMINATION OF THE RETRIEVED IMPLANT. DURING THE ASSESSMENT, IT WAS NOTED THAT THE IMPLANT WAS UNABLE TO BE DISTRACTED AND RETRACTED AND FAILED THE FORCE TESTING. ADDITIONALLY, SURFACE DAMAGE GRADING REVEALED NOTABLE CORROSION, SCRATCHING, GALLING, SURFACE DEPOSITS AND DISCOLORATION. THE REPORT INDICATED THAT THE ROD WAS REMOVED AS PART OF A PLANNED PROCEDURE FOLLOWING THE ACHIEVEMENT OF THE DESIRED LENGTHENING. THE PATIENT HAD PREVIOUSLY REPORTED EXPERIENCING SIGNIFICANT MID-THIGH PAIN, AND RADIOGRAPHIC OBSERVATIONS IDENTIFIED CORTICAL THICKENING AT THE EXTENDABLE JUNCTION OF THE NAIL.

  Patient problems: Implant Pain

  MAUDE report 19912092 ↗