NA 204.080Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982145680), received between Jul 21, 2023 and Mar 31, 2025 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THERE WAS HARDWARE REMOVAL DUE TO NON-UNION. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21732795 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), 2025 THERE WAS HARDWARE REMOVAL DUE TO NON-UNION. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21732668 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, PATIENT UNDERWENT HARDWARE REMOVAL DUE TO NON-UNION. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21732659 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THERE WAS HARDWARE REMOVAL DUE TO NON-UNION. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21732516 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025. THERE WAS HARDWARE REMOVAL DUE TO NON-UNION. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21732499 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THERE WAS HARDWARE REMOVAL DUE TO NON-UNION. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21732482 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THERE WAS HARDWARE REMOVAL DUE TO NON-UNION. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21732458 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, PATIENT UNDERWENT HARDWARE REMOVAL DUE TO NON-UNION. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21732350 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, PATIENT UNDERWENT HARDWARE REMOVAL DUE TO NON-UNION. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21732349 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON MAY 15, 2024 THE PATIENT HAD A HARDWARE REMOVAL DUE TO BROKEN ULNA ABOVE IMPLANT. PATIENT AND SURGICAL STATUS UNKNOWN. ORIGINAL IMPLANT DATE NOT KNOWN. THIS REPORT IS FOR ONE 3.5MM CORTEX SCREW 80MM THIS IS REPORT 8 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 19515804 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON(B)(4) 2024 THE PATIENT HAD A HARDWARE REMOVAL DUE TO BROKEN ULNA ABOVE IMPLANT. PATIENT AND SURGICAL STATUS UNKNOWN. ORIGINAL IMPLANT DATE NOT KNOWN. THIS REPORT IS FOR ONE 3.5MM CORTEX SCREW 80MM THIS IS REPORT 7 OF 8 FOR (B)(4) THIS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 19515748 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON MAY 15, 2024 THE PATIENT HAD A HARDWARE REMOVAL DUE TO BROKEN ULNA ABOVE IMPLANT. PATIENT AND SURGICAL STATUS UNKNOWN. ORIGINAL IMPLANT DATE NOT KNOWN. THIS REPORT IS FOR ONE 3.5MM CORTEX SCREW 80MM THIS IS REPORT 6 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 19515709 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1IT WAS REPORTED ON (B)(6) 2024 THE PATIENT HAD A HARDWARE REMOVAL DUE TO BROKEN ULNA ABOVE IMPLANT. PATIENT AND SURGICAL STATUS UNKNOWN. ORIGINAL IMPLANT DATE NOT KNOWN. THIS REPORT IS FOR ONE 3.5MM CORTEX SCREW 80MM. THIS IS REPORT 4 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 19515705 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2024 THE PATIENT HAD A HARDWARE REMOVAL DUE TO BROKEN ULNA ABOVE IMPLANT. PATIENT AND SURGICAL STATUS UNKNOWN. ORIGINAL IMPLANT DATE NOT KNOWN. THIS REPORT IS FOR ONE 3.5MM CORTEX SCREW 80MM THIS IS REPORT 5 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 19515704 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON MAY 15, 2024 THE PATIENT HAD A HARDWARE REMOVAL DUE TO BROKEN ULNA ABOVE IMPLANT. PATIENT AND SURGICAL STATUS UNKNOWN. ORIGINAL IMPLANT DATE NOT KNOWN. THIS REPORT IS FOR ONE 3.5MM CORTEX SCREW 80MM. THIS IS REPORT 1 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 19515192 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT ON AN UNKNOWN DATE, THERE WAS A REMOVAL OF HARDWARE FOR NON-UNION AND REVISION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 3.5MM CORTEX SCREW 80MM. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17375078 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT ON AN UNKNOWN DATE, THERE WAS A REMOVAL OF HARDWARE FOR NON-UNION AND REVISION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 3.5MM CORTEX SCREW 80MM. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17374763 ↗