IBS™ S25 ST028Recalls & reported problems
In2bones · IBS 2.5-C COMPRESSION SCREW, DIAM2.5 LG 28MM T7 · Class 2 · Implant
All models of IBS (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03760225710173), received between Mar 20, 2026 and Apr 28, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (2 reports).
3 other recalls cover devices cleared under the same FDA submission (K131920); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem2
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Use of Device Problem; Appropriate Device Problem Term/Code Not Available
AT THE TIME OF MANUALLY INSERTING THE SCREW AND VISUALIZING WITH X-RAYS, IT WAS DETECTED THAT THE SCREW WAS BENT. THEREFORE, IT WAS REMOVED AND THIS DEFECT WAS CONFIRMED. IT WAS REPLACED WITH ANOTHER SCREW OF THE SAME SIZE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25012667 ↗MalfunctionMar 20, 2026Use of Device Problem; Insufficient Device Problem Information
DURING THE PROCEDURE, AN IBS 2.5 SCREW BROKE AT ITS MID SECTION. THE SURGEON INSERTED A GUIDE WIRE FOR AN IPD ARTHRODESIS AND ATTEMPTED TO INSERT THE IBS 2.5 SCREW WITH THE MOTOR DRIVER. THE SCREW TWISTED AROUND THE GUIDE WIRE AND FRACTURED, RESULTING IN AN APPROXIMATE 25 MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647073 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131920. One submission often covers many models, so check the product and lot details in each record.
- Z-1319-2024 · Jan 26, 2024 · Open, ClassifiedI.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
- Z-1320-2024 · Jan 26, 2024 · Open, ClassifiedI.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
- Z-0397-2016 · Nov 18, 2015 · TerminatedIBS - Osteosynthesis screws for bone fixation Model S25 ST014.
Other Screw, Fixation, Bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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