NA 02.214.109Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982055439), received between Apr 26, 2019 and Sep 4, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 THE DEVICE IS NOT CAPTURING. THERE WAS NO OPERATION INVOLVED. THERE WAS NO PATIENT INVOLVEMENT OR NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 1.5 CORTEX SCREW SLF-TPNG T4 SD REC 9. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136871 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR A FINGER SURGERY. A VARIABLE ANGLE LOCKING PLATE FOR METACARPAL, ONE (1) CORTEX SCREW AND SIX (6) LOCKING SCREWS WERE REMOVED FROM THE PATIENT DUE TO POSSIBLE INFECTION AND REGRESSION OF THE FUSION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 8969392 ↗
• MalfunctionAug 8, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INCOMING RECEIPT OF A REPLENISHMENT ORDER, THE BAG FOR THE CORTEX SCREW SELF TAPING WITH T4 STAR DRIVE RECESS WAS OBSERVED TO BE EMPTY WHEN THERE SHOULD HAVE BEEN ONE PART IN THE BAG. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A CORTEX SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8875266 ↗
• MalfunctionApr 26, 2019Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2019, THE SURGEON WAS PUTTING A CORTEX SCREW IN A 4TH METACARPAL AND THE HEAD SHEARED OFF. THE 3/4 OF THE SCREW SHAFT WAS LEFT IMPLANTED IN THE PATIENT WHILE THE HEAD AND 1/4 SHAFT WAS REMOVED. THEN, THE DRILL BIT/K-WIRE ATTACHMENT BROKE OFF IN THE PATIENT. THE SURGEON BELIEVES A PREVIOUS FRACTURE IN THE SAME LOCATION COULD HAVE INCREASED THE PATIENT'S BONE DENSITY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. FRAGMENTS WERE GENERATED BUT RETAINED IN THE PATIENT. PATIENT IS STABLE. THIS REPORT IS FOR ONE (1) 1.5 MM CORTEX SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8557774 ↗