NA 214.826Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982154620), received between Mar 22, 2018 and Jun 15, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Unintended Movement” (7 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.

• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DUE TO INFECTION THE PATIENT UNDERWENT FOR A REVISION SURGERY TO REMOVE DEFECTIVE FRACTURED 4.5 MM PROXIMAL TIBIAL PLATE AND OTHER ASSOCIATED SCREWS. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 26MM. THIS REPORT IS 3 OF 7 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

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

  MAUDE report 12001877 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO A MEDIAL TIBIA WOUND, AND THE FRACTURE WAS HEALED. INITIALLY, THE PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) PLATING SYSTEM ON AN UNKNOWN DATE. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 26MM. THIS REPORT IS 2 OF 10 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11132517 ↗
• InjuryMar 22, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT INITIAL OPEN REDUCTION AND INTERNAL FIXATION (ORIF) HUMERAL SHAFT SURGERY AND THE PATIENT WAS IMPLANTED WITH A PLATE AND SEVEN (7) SCREWS. PATIENT UNDERWENT REVISION OF ORIF HUMERAL SHAFT DUE TO LOOSENING OF THE PROXIMAL SCREWS FROM THE PLATE CAUSING A NONUNION OF THE FRACTURE. DURING THE REVISION, THE PLATE AND SCREWS WERE REMOVED, AND A HUMERAL NAIL AND THREE (3) LOCKING SCREWS WERE IMPLANTED TO STABILIZE THE FRACTURE. CONCOMITANT DEVICE REPORTED: 4.5 MM NARROW LCP® PLATE 10 HOLES/188 MM (PART# 224.601, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5 MM CORTEX SCREW SELF-TAPPING 26 MM. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7361673 ↗
• InjuryMar 22, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT INITIAL OPEN REDUCTION AND INTERNAL FIXATION (ORIF) HUMERAL SHAFT SURGERY AND THE PATIENT WAS IMPLANTED WITH A PLATE AND SEVEN (7) SCREWS. PATIENT UNDERWENT REVISION OF ORIF HUMERAL SHAFT DUE TO LOOSENING OF THE PROXIMAL SCREWS FROM THE PLATE CAUSING A NONUNION OF THE FRACTURE. DURING THE REVISION, THE PLATE AND SCREWS WERE REMOVED, AND A HUMERAL NAIL AND THREE (3) LOCKING SCREWS WERE IMPLANTED TO STABILIZE THE FRACTURE. CONCOMITANT DEVICE REPORTED: 4.5MM NARROW LCP® PLATE 10 HOLES/188MM (PART# 224.601, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 26MM. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7361670 ↗
• InjuryMar 22, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT INITIAL OPEN REDUCTION AND INTERNAL FIXATION (ORIF) HUMERAL SHAFT SURGERY AND THE PATIENT WAS IMPLANTED WITH A PLATE AND SEVEN (7) SCREWS. PATIENT UNDERWENT REVISION OF ORIF HUMERAL SHAFT DUE TO LOOSENING OF THE PROXIMAL SCREWS FROM THE PLATE CAUSING A NONUNION OF THE FRACTURE. DURING THE REVISION, THE PLATE AND SCREWS WERE REMOVED, AND A HUMERAL NAIL AND THREE (3) LOCKING SCREWS WERE IMPLANTED TO STABILIZE THE FRACTURE. CONCOMITANT DEVICE REPORTED: 4.5 MM NARROW LCP® PLATE 10 HOLES/188 MM (PART# 224.601, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5 MM CORTEX SCREW SELF-TAPPING 26 MM. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7361666 ↗
• InjuryMar 22, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT INITIAL OPEN REDUCTION AND INTERNAL FIXATION (ORIF) HUMERAL SHAFT SURGERY AND THE PATIENT WAS IMPLANTED WITH A PLATE AND SEVEN (7) SCREWS. PATIENT UNDERWENT REVISION OF ORIF HUMERAL SHAFT DUE TO LOOSENING OF THE PROXIMAL SCREWS FROM THE PLATE CAUSING A NONUNION OF THE FRACTURE. DURING THE REVISION, THE PLATE AND SCREWS WERE REMOVED, AND A HUMERAL NAIL AND THREE (3) LOCKING SCREWS WERE IMPLANTED TO STABILIZE THE FRACTURE. CONCOMITANT DEVICE REPORTED: 4.5 MM NARROW LCP® PLATE 10 HOLES/188 MM (PART# 224.601, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5 MM CORTEX SCREW SELF-TAPPING 26 MM. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7361651 ↗
• InjuryMar 22, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT INITIAL OPEN REDUCTION AND INTERNAL FIXATION (ORIF) HUMERAL SHAFT SURGERY AND THE PATIENT WAS IMPLANTED WITH A PLATE AND SEVEN (7) SCREWS. PATIENT UNDERWENT REVISION OF ORIF HUMERAL SHAFT DUE TO LOOSENING OF THE PROXIMAL SCREWS FROM THE PLATE CAUSING A NONUNION OF THE FRACTURE. DURING THE REVISION, THE PLATE AND SCREWS WERE REMOVED, AND A HUMERAL NAIL AND THREE (3) LOCKING SCREWS WERE IMPLANTED TO STABILIZE THE FRACTURE. CONCOMITANT DEVICE REPORTED: 4.5MM NARROW LCP® PLATE 10 HOLES/188MM (PART# 224.601, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 26MM. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7361646 ↗
• InjuryMar 22, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT INITIAL OPEN REDUCTION AND INTERNAL FIXATION (ORIF) HUMERAL SHAFT SURGERY AND THE PATIENT WAS IMPLANTED WITH A PLATE AND SEVEN (7) SCREWS. PATIENT UNDERWENT REVISION OF ORIF HUMERAL SHAFT DUE TO LOOSENING OF THE PROXIMAL SCREWS FROM THE PLATE CAUSING A NONUNION OF THE FRACTURE. DURING THE REVISION, THE PLATE AND SCREWS WERE REMOVED, AND A HUMERAL NAIL AND THREE (3) LOCKING SCREWS WERE IMPLANTED TO STABILIZE THE FRACTURE. CONCOMITANT DEVICE REPORTED: 4.5 MM NARROW LCP® PLATE 10 HOLES/188 MM (PART# 224.601, LOT# UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) 4.5 MM CORTEX SCREW SELF-TAPPING 26 MM. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7361642 ↗
• InjuryMar 22, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT INITIAL OPEN REDUCTION AND INTERNAL FIXATION (ORIF) HUMERAL SHAFT SURGERY AND THE PATIENT WAS IMPLANTED WITH A PLATE AND SEVEN (7) SCREWS. PATIENT UNDERWENT REVISION OF ORIF HUMERAL SHAFT DUE TO LOOSENING OF THE PROXIMAL SCREWS FROM THE PLATE CAUSING A NONUNION OF THE FRACTURE. DURING THE REVISION, THE PLATE AND SCREWS WERE REMOVED, AND A HUMERAL NAIL AND THREE (3) LOCKING SCREWS WERE IMPLANTED TO STABILIZE THE FRACTURE. CONCOMITANT DEVICE REPORTED: 4.5MM NARROW LCP® PLATE 10 HOLES/188MM (PART# 224.601, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 26MM. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7361637 ↗