Cortex Screw, 3.5mm x 44mm, T15, Flex-Thread™ 8428-44-SRecalls & reported problems
Flower Orthopedics Corporation · 3.5mm x 44mm, T15, Bone screw · Class 2 · Implant
Data updated Oct 18, 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 00840118117272), received between Nov 23, 2021 and Nov 23, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 23, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE EVENT INCLUDED THE BACKING OUT OF TWO NON-LOCKING CORTEX SCREWS, WHICH WAS DISCOVERED USING X-RAY 26 DAYS POST-IMPLANTATION. A REVISION SURGERY IS SCHEDULED TO BE PERFORMED ON (B)(6) 2021. THIS EVENT IS ASSOCIATED WITH THE SAME PATIENT AND SURGICAL PROCEDURE AS DESCRIBED IN MDR 3009996260-2021-00016.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12861887 ↗
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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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