NA 02.206.285Recalls & reported problems
Synthes GmbH · 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/85MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982051608), received between May 29, 2025 and May 29, 2025 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Malunion of Bone1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 116 PATIENTS THAT WERE IMPLANTED WITH THE LCP HOOK PLATE SYSTEM 3.5MM BETWEEN OCTOBER 2015 TO FEBRUARY 2023 AT SANFORD RESEARCH. SUBJECT ID 12: A 74-YEAR-OLD MALE PATIENT WHO UNDERWENT FRACTURE FIXATION (OPEN REDUCTION INTERNAL FIXATION LEFT ANKLE). POSTOPERATIVE COMPLICATIONS AND TREATMENT/INTERVENTION INCLUDE: - INADEQUATE FIXATION LEADING TO MALUNION, HARDWARE FAILURE REQUIRING TIBIOTALOCALCANEAL ARTHRODESIS WITH IM NAIL IMPLANT(S) INVOLVED: 02.113.103. CORTEX SCREWS X 1 - 02.206.285. THIS COMPLAINT INVOLVES A TOTAL OF 12 IDENTIFIED PATIENTS. THIS PC IS CREATED TO CAPTURE SUBJECT ID 12. THIS IS RELATED TO (B)(4).
Patient problems: Malunion of Bone
MAUDE report 22104304 ↗
Other Screw, fixation, bone devices
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- 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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