PRECICE STRYDE System PS10.0-50B235Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887517950741), received between Sep 3, 2020 and Jun 14, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Corroded” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT METALLOSIS WAS SUSPECTED ON X-RAYS AND LATER CONFIRMED UPON EXPLANT. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 14684715 ↗
• MalfunctionDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT THE PATIENT DEVELOPED A BONY FISTULA AND COMPLAINED OF PAIN.

  Patient problems: Fistula; Pain

  MAUDE report 13010839 ↗
• MalfunctionJun 29, 2021Corroded; Corroded

  INFORMATION WAS RECEIVED THAT AFTER BEING EXPLANTED, THE NAIL WAS NOTED TO HAVE CORROSION ON THE PROXIMAL PORTION OF THE LENGTHENING ROD. NO PATIENT IMPACT OR ADVERSE EVENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089621 ↗
• MalfunctionJun 29, 2021Corroded; Corroded

  INFORMATION WAS RECEIVED THAT AFTER BEING EXPLANTED, THE NAIL WAS NOTED TO HAVE CORROSION ON THE PROXIMAL PORTION OF THE LENGTHENING ROD. NO PATIENT IMPACT OR ADVERSE EVENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089620 ↗
• InjurySep 3, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT THE NAIL WAS IMPLANTED AND THEN REMOVED UPON NOTICING IT WAS DEFECTIVE AS THE SCREW HOLES WERE FLIPPED 90 DEGREES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10492084 ↗