NA 204.812Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982146243), received between Oct 17, 2018 and Jul 20, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT REVISED THE PLATE DUE TO SCREWS PULLING OUT .IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 12MM. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15070875 ↗
• InjuryJul 20, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT REVISED THE PLATE DUE TO SCREWS PULLING OUT .IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1)3.5MM CORTEX SCREW SELF-TAPPING 12MM THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15070780 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 12MM. THIS IS REPORT 9 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13591152 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 12MM. THIS IS REPORT 10 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13591148 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 12MM. THIS IS REPORT 12 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13591142 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 12MM. THIS IS REPORT 11 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13591135 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE HARDWARE IN QUESTION WAS REMOVED DUE TO INFECTION. IT IS UNKNOWN WHEN THE HARDWARE WAS ORIGINALLY IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 12MM. THIS IS REPORT 7 OF 11 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 12489362 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO PAIN ON (B)(6) 2018. HARDWARE REMOVED DURING THE PROCEDURE INVOLVES ONE (1) LOCKING COMPRESSION PLATE (LCP) ONE-THIRD TUBULAR PLATE WITH COLLAR, ONE (1) VARIABLE ANGLE LCP MEDIAL DISTAL TIBIA PLATE, SEVEN (7) CORTEX SCREWS, TWO (2) LOCKING SCREWS WITH STARDRIVE AND FIVE (5) VARIABLE ANGLE LOCKING SCREWS WITH T8 STARDRIVE. THE HARDWARE WAS IMPLANTED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS BROKE. THE BROKEN SCREWS WERE FULLY REMOVED. THE BONE WAS HEALED AND NO ADDITIONAL HARDWARE WAS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT ADDRESSES THE REVISION SURGERY DUE TO PAIN. ADDITIONAL PRODUCTS INVOLVED ARE ADDRESSED IN (B)(4). THE INTRAOPERATIVE ISSUE WITH THE BROKEN SCREWS IS ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7978677 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO PAIN. THERE WERE (1) LOCKING COMPRESSION PLATE (LCP) TUBULAR PLATE WITH COLLAR, ONE (1) VARIABLE ANGLE LCP MEDIAL DISTAL TIBIA PLATE, SEVEN (7) CORTEX SCREWS, TWO (2) LOCKING SCREWS WITH STARDRIVE AND FIVE (5) VARIABLE ANGLE LOCKING SCREWS WITH T8 STARDRIVE WERE REMOVED. THE HARDWARE WAS IMPLANTED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS BROKE. THE BROKEN SCREWS WERE FULLY REMOVED. THE BONE WAS HEALED AND NO ADDITIONAL HARDWARE WAS PLACED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THE LINKED COMPLAINT (B)(4) FOR THE ADDITIONAL SIX DEVICES THIS COMPLAINT INVOLVES TEN 10 OF THE 16 DEVICES. THIS COMPLAINT IS FOR ONE 3.5MM CORTEX SCREW SELF-TAPPING 12MM. THIS REPORT IS 5 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7976003 ↗