PRECICE STRYDE SystemRecalls & reported problems across all models
Nuvasive Specialized Orthopedics, Inc. · 231 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one PRECICE STRYDE System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 139
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 2
We found 231 models of PRECICE STRYDE System by Nuvasive Specialized Orthopedics, Inc. in the FDA's device registry (GUDID). Together they are named in 139 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2019 and Feb 18, 2025 — classified as 52 injuries, 87 malfunctions.
The most frequently reported specific device problem is “Corroded” (47 reports).
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PRECICE STRYDE System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 216 of these models · Recall details · FDA record ↗
- 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 · names 231 of these models · Recall details · FDA record ↗
Most reported PRECICE STRYDE System problems
Device problems
- Corroded47
- Break30
- Material Discolored27
- Adverse Event Without Identified Device or Use Problem17
- Defective Device12
- Physical Resistance/Sticking12
- Mechanical Problem10
- Fracture4
Patient problems
- Failure of Implant46
- No Clinical Signs, Symptoms or Conditions36
- Pain26
- Osteolysis20
- Inflammation7
- Insufficient Information7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Implant Pain6
PRECICE STRYDE System models
231 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- PRECICE® STRYDE System PS10.0-80D265Rod, Fixation, Intramedullary And Accessories2 recalls12 reports
- PRECICE® STRYDE System PS11.5-80D265Rod, Fixation, Intramedullary And Accessories2 recalls6 reports
- PRECICE STRYDE System PS10.0-50B235Rod, Fixation, Intramedullary And Accessories2 recalls5 reports
- PRECICE® STRYDE System PS10.0-80D335Rod, Fixation, Intramedullary And Accessories2 recalls5 reports
- PRECICE® STRYDE System PS11.5-80D280Rod, Fixation, Intramedullary And Accessories2 recalls5 reports
- PRECICE® STRYDE System PS10.0-80SJ265Rod, Fixation, Intramedullary And Accessories2 recalls5 reports
- PRECICE® STRYDE System PS10.0-80B265Rod, Fixation, Intramedullary And Accessories2 recalls4 reports
- PRECICE® STRYDE System PS13.0-80B280Rod, Fixation, Intramedullary And Accessories2 recalls4 reports
- PRECICE® STRYDE System PS10.0-80D280Rod, Fixation, Intramedullary And Accessories2 recalls4 reports
- PRECICE® STRYDE System PS11.5-80SJ265Rod, Fixation, Intramedullary And Accessories2 recalls4 reports
- PRECICE® STRYDE System PS10.0-80B280Rod, Fixation, Intramedullary And Accessories2 recalls3 reports
- PRECICE® STRYDE System PS11.5-80B265Rod, Fixation, Intramedullary And Accessories2 recalls3 reports
- PRECICE® STRYDE System PS11.5-80B280Rod, Fixation, Intramedullary And Accessories2 recalls3 reports
- PRECICE® STRYDE System PS11.5-50D235Rod, Fixation, Intramedullary And Accessories2 recalls3 reports
- PRECICE® STRYDE System PS10.0-65SJ250Rod, Fixation, Intramedullary And Accessories2 recalls3 reports
- PRECICE® STRYDE System PS11.5-80SJ280Rod, Fixation, Intramedullary And Accessories2 recalls3 reports
- PRECICE® STRYDE System PS10.0-80B335Rod, Fixation, Intramedullary And Accessories2 recalls2 reports
- PRECICE® STRYDE System PS11.5-50B235Rod, Fixation, Intramedullary And Accessories2 recalls2 reports
- PRECICE® STRYDE System PS13.0-50D235Rod, Fixation, Intramedullary And Accessories2 recalls2 reports
- PRECICE® STRYDE System PS11.5-50SJ235Rod, Fixation, Intramedullary And Accessories2 recalls2 reports
- PRECICE® STRYDE System PS11.5-80SJ305Rod, Fixation, Intramedullary And Accessories2 recalls2 reports
- PRECICE® STRYDE System STP4-400Screw, Fixation, Bone2 recalls2 reports
- PRECICE® STRYDE System PS11.5-80A265Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System PS10.0-65B250Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System PS11.5-65B250Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System PS11.5-80B335Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System PS13.0-65B250Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System PS13.0-80B335Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System PS10.0-80C305Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System PS11.5-80D335Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System PS11.5-80D365Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System PS13.0-80D265Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System PS10.0-80SJ280Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System PS10.0-80SJ305Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System PS11.5-65SJ250Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® STRYDE System STP4-325Screw, Fixation, Bone2 recalls1 report
- PRECICE® STRYDE System STP4-375Screw, Fixation, Bone2 recalls1 report
- PRECICE® STRYDE System STP4-500Screw, Fixation, Bone2 recalls1 report
- PRECICE® STRYDE System STP4.5-350Screw, Fixation, Bone2 recalls1 report
- PRECICE® STRYDE System STP5-350Screw, Fixation, Bone2 recalls1 report
- PRECICE® STRYDE System STP5-400Screw, Fixation, Bone2 recalls1 report
- PRECICE® STRYDE System STP5-500Screw, Fixation, Bone2 recalls1 report
- PRECICE® STRYDE System STP5-700Screw, Fixation, Bone2 recalls1 report
- PRECICE® STRYDE System PS10.0-65A250Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80A305Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80A335Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80A365Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-50A235Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-65A250Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-80A280Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-80A305Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-80A335Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-80A365Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-50A235Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-65A250Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80A280Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80A305Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80A335Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80A365Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80B305Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80B365Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-80B305Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-80B365Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-50B235Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80B265Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80B305Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80B365Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-65C250Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80C265Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80C280Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80C335Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80C365Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-50C235Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-65C250Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-80C265Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-80C305Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-80C335Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-80C365Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-50C235Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-65C250Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80C265Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80C280Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80C305Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80C335Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80C365Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80D365Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-65D250Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-80D305Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-65D250Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80D280Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80D305Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80D335Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS13.0-80D365Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-65E250Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80E265Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80E280Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80E305Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80E335Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS10.0-80E365Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® STRYDE System PS11.5-50E235Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
Recent PRECICE STRYDE System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2025Break; Break
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WILL BE PERFORMED DUE TO A BROKEN NAIL BEING DISCOVERED VIA X-RAY.
Patient problems: Failure of Implant
MAUDE report 21403209 ↗MalfunctionFeb 11, 2025Break; Break
INFORMATION WAS RECEIVED THAT A REMOVAL PROCEDURE WAS PERFORMED DUE TO TWO BROKEN FEMORAL NAILS. THE NAILS WERE DIFFICULT TO REMOVE FROM THE BONE, RESULTING IN REMOVAL OF ONLY THE SCREWS AND PROXIMAL PORTION OF THE NAILS. THE UNIVERSAL REMOVAL KIT WAS USED REMOVAL OF ALL PORTIONS OF THE NAIL WAS UNSUCCESSFUL. DUE TO THIS THE PATIENT'S PROCEDURE WAS PROLONGED.
Patient problems: Failure of Implant
MAUDE report 21355203 ↗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 19912265 ↗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 MILD THIGH PAIN, AND RADIOGRAPHIC OBSERVATIONS IDENTIFIED CORTICAL THICKENING AT THE EXTENDABLE JUNCTION OF THE NAIL.
Patient problems: Implant Pain
MAUDE report 19912262 ↗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 AILED 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 19912219 ↗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 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 ↗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 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: Insufficient Information
MAUDE report 19911908 ↗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 ↗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 COULD BE DISTRACTED AND RETRACTED 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. RADIOGRAPHIC OBSERVATIONS IDENTIFIED CORTICAL THICKENING AT THE EXTENDABLE JUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19908668 ↗MalfunctionJul 26, 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 THIGH PAIN, AND RADIOGRAPHIC OBSERVATIONS IDENTIFIED CORTICAL THICKENING AT THE EXTENDABLE JUNCTION OF THE NAIL.
Patient problems: Implant Pain
MAUDE report 19838940 ↗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 ↗InjuryAug 31, 2023Break; Break
INFORMATION WAS RECEIVED THAT UPON EXTRACTION OF THE NAIL, THE PROXIMAL END OF THE NAIL BROKE AWAY AT THE SCREW HOLE LEAVING THE DISTAL PORTION OF THE NAIL IN THE PATIENT'S FEMUR. THE SURGEON HAD TO ENTER THE DISTAL SIDE OF THE PATIENT FEMUR, OPENING THE PATIENT UP ABOVE THE KNEE TO PUSH THE DISTAL PORTION OF THE NAIL THROUGH TO COMPLETE THE EXTRACTION PROCESS WHICH RESULTED IN A 5 HOUR SURGERY. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAS SUFFERED A FRACTURE OF THE FEMUR DUE TO THE INTERVENTION REQUIRED TO REMOVE THE NAIL FOLLOWING THE BREAKAGE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 17662512 ↗
Other Nuvasive Specialized Orthopedics, Inc. products
- MAGEC Spinal Bracing and Distraction System29 models · 663 reports · 1 recall
- PRECICE Intramedullary Limb Lengthening System551 models · 177 reports · 4 recalls
- PRECICE Bone Transport System561 models · 28 reports · 3 recalls
- PRECICE Plating System67 models · 24 reports · 3 recalls
- PRECICE Trauma Nail System182 models · 4 reports · 3 recalls
- FREEDOM Residual Limb Lengthening System2 models · 1 reports · 2 recalls
- Precice38 models · 9 reports · 1 recall
- PRECICE System15 models · 0 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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