NA 204.026Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982145413), received between Mar 12, 2022 and Apr 1, 2022 — classified as 7 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A REVISION SURGERY DUE TO NON-UNION/MALUNION. REMOVAL OF 18 HOLE, 3.5MM CURVED LCP PLATE FROM FEMUR, AS WELL AS 6X 3.5MM CORTEX SCREWS WAS PERFORMED. A REVISION SURGERY WAS DONE, AND THE SURGEON INSERTED AN ADOLESCENT LATERAL ENTRY FEMORAL NAIL. THIS REPORT INVOLVES ONE (1) CORTEX SCREW. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13978300 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A REVISION SURGERY DUE TO NON-UNION/MALUNION. REMOVAL OF 18 HOLE, 3.5MM CURVED LCP PLATE FROM FEMUR, AS WELL AS 6X 3.5MM CORTEX SCREWS WAS PERFORMED. A REVISION SURGERY WAS DONE, AND THE SURGEON INSERTED AN ADOLESCENT LATERAL ENTRY FEMORAL NAIL. THIS REPORT INVOLVES ONE (1) CORTEX SCREW. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13978229 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A REVISION SURGERY DUE TO NON-UNION/MALUNION. REMOVAL OF 18 HOLE, 3.5MM CURVED LCP PLATE FROM FEMUR, AS WELL AS 6X 3.5MM CORTEX SCREWS WAS PERFORMED. A REVISION SURGERY WAS DONE, AND THE SURGEON INSERTED AN ADOLESCENT LATERAL ENTRY FEMORAL NAIL. THIS REPORT INVOLVES ONE (1) CORTEX SCREW. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13978197 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A REVISION SURGERY DUE TO NON-UNION/MALUNION. REMOVAL OF 18 HOLE, 3.5MM CURVED LCP PLATE FROM FEMUR, AS WELL AS 6X 3.5MM CORTEX SCREWS WAS PERFORMED. A REVISION SURGERY WAS DONE, AND THE SURGEON INSERTED AN ADOLESCENT LATERAL ENTRY FEMORAL NAIL. THIS REPORT INVOLVES ONE (1) CORTEX SCREW. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13978187 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A REVISION SURGERY DUE TO NON-UNION/MALUNION. REMOVAL OF 18 HOLE, 3.5MM CURVED LCP PLATE FROM FEMUR, AS WELL AS 6X 3.5MM CORTEX SCREWS WAS PERFORMED. A REVISION SURGERY WAS DONE, AND THE SURGEON INSERTED AN ADOLESCENT LATERAL ENTRY FEMORAL NAIL. THIS REPORT INVOLVES ONE (1) CORTEX SCREW. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13978152 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A REVISION SURGERY DUE TO NON-UNION/MALUNION. REMOVAL OF 18 HOLE, 3.5MM CURVED LCP PLATE FROM FEMUR, AS WELL AS 6X 3.5MM CORTEX SCREWS WAS PERFORMED. A REVISION SURGERY WAS DONE, AND THE SURGEON INSERTED AN ADOLESCENT LATERAL ENTRY FEMORAL NAIL. THIS REPORT INVOLVES ONE (1) CORTEX SCREW. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13978141 ↗
• InjuryMar 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT REPORTS WITH PAIN, EFFUSION, DRAINAGE, AND AN INADVERTENT ARTHROTOMY OF THE LEFT KNEE STATUS POST IT BAND RELEASE AND TIBIAL INSERT REVISION. PHYSICIAN CONFIRMS A RECURRENT SUPERFICIAL WOUND DEHISCENCE OF THE SURGICAL SITE WITH DRAINAGE ON THE LATERAL ASPECT DUE TO THINNED SKIN SECONDARY TO THE IT BAND DEBULKING. THE JOINT CAPSULE ARTHROTOMY IS BULGING BUT IS INTACT. THE FLUID ACCUMULATION AFTER PHYSICAL THERAPY IS CAUSING THE SURGICAL SITE TO BREAK OPEN TO DRAIN. PATIENT IS PUT ON RESTRICTIVE MOVEMENT, GIVEN A COMPRESSIVE BANDAGE, STERI STRIPS, AND PROPHYLACTIC ORAL ANTIBIOTICS. ON (B)(6) 2022 THE WOUND DEHISCENCE IS HEALED WITH A SLIGHT BULGE. THE SITE IS CLEAN AND DRY WITH NO SIGN OF INFECTION, ERYTHEMA, OR SWELLING. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW 26MM. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4) AND (B)(4). (B)(4) CAPTURES THE SURGICAL IT BAND RELEASE AND (B)(4) CAPTURES THE REVISION OF TIBIAL INSERT.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 13742087 ↗