Biosteon® Screw 234-010-161Recalls & reported problems
Biocomposites Ltd · The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-latic) Acid and calcium phosphate which will be gradually resorbed into the body. This function however, is patient dependent. · Class 2 · Implant
All models of Biosteon Screw (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 15060155710249), received between Sep 19, 2018 and Apr 4, 2022 — classified as 13 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (13 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
- Break13
- Material Integrity Problem7
- Material Fragmentation3
- Detachment of Device or Device Component1
- Entrapment of Device1
Patient problems
- Device Embedded In Tissue or Plaque6
- Foreign Body In Patient5
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2022Break
IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND POTENTIALLY REMAINS IN THE JOINT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 14002191 ↗InjuryJan 7, 2022Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE AND POTENTIALLY REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 13195404 ↗InjuryAug 12, 2021Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND POTENTIALLY REMAINED IN THE JOINT.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 12316603 ↗InjuryAug 12, 2021Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND POTENTIALLY REMAINED IN THE JOINT.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 12316602 ↗InjuryJun 17, 2021Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND POTENTIALLY REMAINED IN THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12018023 ↗InjuryJan 14, 2021Break; Material Fragmentation
IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND THE TIP REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 11175303 ↗InjuryJul 1, 2020Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE AND A PIECE REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 10221148 ↗InjuryJun 15, 2020Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT THE SCREW BROKE AND POTENTIALLY REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10154084 ↗InjuryMay 18, 2020Material Fragmentation; Break; Entrapment of Device; Material Fragmentation
IT WAS REPORTED THAT A BROKEN PIECE OF THE DEVICE REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10065693 ↗InjuryOct 7, 2019Break; Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE SCREW BROKE AND PIECES REMAINED IN THE JOINT.
Patient problems: Foreign Body In Patient
MAUDE report 9161985 ↗InjuryJul 22, 2019Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT THE SCREW BROKE AND PART OF SCREW WAS LEFT INSIDE THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8814078 ↗InjuryJul 11, 2019Break
IT WAS REPORTED THAT THE DEVICE BROKE IN THE JOINT. MULTIPLE ATTEMPTS WERE MADE TO GATHER MORE INFORMATION, HOWEVER NO NEW INFORMATION WAS RECEIVED.
Patient problems: No Code Available
MAUDE report 8783060 ↗InjuryJan 30, 2019Detachment of Device or Device Component
IT WAS REPORTED THAT PART OF SCREW WAS LEFT INSIDE THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8288985 ↗InjurySep 19, 2018Break
IT WAS REPORTED THAT THE SCREW BROKE IN THE PATIENTS BONE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7890715 ↗
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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