PRECICE® STRYDE System PS10.0-50SJ235Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887517951595), received between Oct 5, 2020 and Aug 5, 2024 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Corroded” (8 reports).

1 FDA recall record name this device's identifier, 1 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 18, 2026.

Recalls naming this device

1. Feb 12, 2021Class IIOpen, 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 12 most recent of 12 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 DIDN'T INDICATE THE REASON FOR REMOVAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19912135 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912097 ↗
• 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 DIDN'T INDICATE THE REASON FOR REMOVAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19912044 ↗
• 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 ABLE TO BE DISTRACTED AND RETRACTED AND PASSED 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 MID-THIGH PAIN.

  Patient problems: Implant Pain

  MAUDE report 19911892 ↗
• MalfunctionJul 26, 2024Corroded; Material Discolored; Material Erosion; Physical Resistance/Sticking; Corroded; Material Discolored; Material Erosion; 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 COULD BE DISTRACTED AND RETRACTED AND PASSED THE FORCE TESTING. ADDITIONALLY, SURFACE DAMAGE GRADING REVEALED NOTABLE MATERIAL WEAR, CORROSION, SCRATCHING, DISCOLORATION, AND GALLING. 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 SEVERE PAIN, AND RADIOGRAPHIC OBSERVATIONS IDENTIFIED CORTICAL THICKENING AT THE EXTENDABLE JUNCTION OF THE LEFT NAIL. FURTHERMORE, IT WAS DETERMINED THAT THERE WAS PERIPROSTHETIC FIBROUS TISSUE WITH FOCAL METALLIC DEBRIS. MICROBIOLOGY FINDINGS TAKEN ON (B)(6) 2020 REVEALED THAT THE TISSUE HAD STAPH EPIDERMIDIS AND PAENICLOSTRIDIUM SORDELLII. REPORT 1 OF 2.

  Patient problems: Bacterial Infection; Implant Pain; Metal Related Pathology; Skin Infection

  MAUDE report 19838645 ↗
• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT ON AN UNKNOWN DATE A REVISION PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. ADDITIONALLY IT WAS REPORTED THAT THE PATIENT HAD HIGH LEVELS OF CERTAIN METALS IN THEIR BLOOD. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 14522676 ↗
• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT ON AN UNKNOWN DATE A REVISION PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. ADDITIONALLY IT WAS REPORTED THAT THE PATIENT HAD HIGH LEVELS OF CERTAIN METALS IN THEIR BLOOD. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 14522549 ↗
• InjurySep 2, 2021Corroded; Corroded

  INFORMATION WAS RECEIVED THAT THE PATIENT HAD LYTIC-HYPERTROPHIC OSTEOLYSIS AND REPORTED PAIN DURING CONSOLIDATION AND DISTRACTION. ADDITIONALLY, IT WAS REPORTED THAT THE IMPLANT HAD CORROSION.

  Patient problems: Osteolysis; Pain

  MAUDE report 12417284 ↗
• MalfunctionJul 13, 2021Break; Corroded; Break; Corroded

  INFORMATION WAS RECEIVED THAT THE NAIL WAS BROKEN AND THE PATIENT COMPLAINED OF PAIN. UPON EXPLANT CORROSION WAS SEEN ON THE NAIL.

  Patient problems: Pain

  MAUDE report 12161386 ↗
• MalfunctionJun 2, 2021Material Erosion; Material Erosion

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925166 ↗
• InjuryMar 29, 2021Corroded; Corroded

  ADDITIONAL INFORMATION WAS RECEIVED VIA REVIEW OF LITERATURE THAT THE PATIENT EXPERIENCED SEVERE PAIN ON THE RIGHT LOWER LEG.

  Patient problems: Pain

  MAUDE report 11586723 ↗
• InjuryOct 5, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020 DUE TO LOCALIZED PAIN IN THE DISTAL TIBIA. X-RAYS WERE TAKEN WHICH SHOWED OSTEOLYSIS AND OSTEOMYELITIS WHERE THE NAIL WAS TELESCOPED.

  Patient problems: Erythema; Osteolysis; Pain

  MAUDE report 10632295 ↗