NA 02.200.090Recalls & reported problems
Synthes GmbH · 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 90MM · 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 10886982048073), received between Apr 27, 2023 and Aug 9, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
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.
MalfunctionAug 9, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SCREW IS BENT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 90MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17494358 ↗InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2022, TO IMPLANT THE DEVICE. ON (B)(6) 2023, IT APPEARED THAT THE PATIENT HAD DEVELOPED A REACTION ISSUE WITH THE TITANIUM IN HIS LOWER LEG. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 9 OF 11 FOR (B)(4). THIS REPORT INVOLVES ONE (1) 3.5 SD CORTEX SCREW SELF-TAPPING 90.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 16824995 ↗
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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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