NA 02.206.218Recalls & reported problems
Synthes GmbH · 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/18MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982050960), received between Mar 17, 2022 and Feb 1, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCT IN QUESTION WAS DELIVERED BUT WAS MISSING OUT OF THE ORIGINAL PACKAGING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/18MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18626216 ↗InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON UNKNOWN DATE, A PATIENT HAD FULL BODY RASH WHICH BEGAN AFTER AN ANKLE FRACTURE REPAIR WITH ONE (1) 3.5 MM LCP ONE-THIRD TUBULAR PLATE AND EIGHT (8) 3.5 MM CORTEX SCREWS. ALLERGY TESTING HAS CONFIRMED THE PATIENT IS ALLERGIC TO INDIUM (III) CHLORIDE, A COMPOUND FOUND IN SOME METAL ALLOYS WHICH MAYBE OF THE IMPLANTS. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/18MM THIS IS REPORT 9 OF 9 FOR COMPLAINT (B)(4).
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 13793221 ↗
Other Screw, fixation, bone devices
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- 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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