Biosteon® Screw 234-010-179Recalls & reported problems
Biocomposites Ltd · The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lactic) Acid and Calcium Phosphate, which will be gradually resorbed into the body, this function however, is patient dependant. · Class 2 · Implant
All models of Biosteon Screw (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15060155710331), received between Sep 25, 2019 and Mar 17, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (4 reports).
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.
Most reported problems
Device problems
- Break4
- Material Fragmentation2
- Material Integrity Problem1
Patient problems
- Device Embedded In Tissue or Plaque3
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2022Break
IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND POTENTIALLY REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 13792814 ↗InjuryJan 7, 2022Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 13192575 ↗InjuryOct 7, 2019Break; Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE SCREW BROKE AND PIECES WERE LEFT INSIDE OF THE JOINT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9161992 ↗InjurySep 25, 2019Break; Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DEVICE BROKE AND SOME PARTS OF THE SCREW WERE LEFT IN THE JOINT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9120592 ↗
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 STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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