NA 202.850Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982144928), received between Jun 11, 2019 and Nov 7, 2021 — classified as 1 injury, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE FOR AN OPEN REDUCTION INTERNAL FIXATION OF PROXIMAL FEMUR THE SCREW HEADS WAS BROKEN. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS AS PLANNED. THIS REPORT IS FOR ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 45MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758815 ↗
• InjuryJun 11, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE EXTENDED MEDIAL DISTAL HUMERUS PLATES, ONE (1) CORTEX SCREW SELF-TAPPING 50 MM, ONE (1) CORTEX SCREW SELF-TAPPING 20 MM, ONE (1) CORTEX SCREW SELF-TAPPING 24 MM, THREE (3) CORTEX SCREWS SELF-TAPPING 20 MM, ONE (1) CORTEX SCREW SELF-TAPPING 22 MM, ONE (1) CORTEX SCREW SELF-TAPPING 26 MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14 MM, ONE VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16 MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22 MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30 MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40 MM AND ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50 MM. SOME SCREWS WERE BROKEN AND LEFT. OTHER SCREWS WERE LEFT IN THE BODY. IT IS UNKNOWN IF WHAT SCREWS WERE LEFT/BROKEN. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY

  Patient problems: No Code Available; Pain

  MAUDE report 8686816 ↗