NA 204.822Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982146298), received between Oct 17, 2018 and Jan 6, 2023 — 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES IN 2016. THE PATIENT FOUND OUT THAT THERE WAS A PROBLEM WITH THE IMPLANTS APPROXIMATELY 2 MONTHS AGO WHEN HE WENT TO THE ER BECAUSE HIS ARM WAS BAD, AND X-RAYS WERE TAKEN. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE HARDWARE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM CORTEX SCREW SELF-TAPPING 22MM. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16113689 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS INVOLVED IN AN INCIDENT AT WORK THAT RESULTED IN MULTIPLE INJURIES, ONE OF WHICH WAS A FRACTURE TO HIS ARM. TO REPAIR THE FRACTURE, THE SURGEON PLACED AN IMPLANT IN THE PATIENT'S ARM. ON (B)(6) 2019, THE IMPLANT BROKE CAUSING ANOTHER FRACTURE TO THE PATIENT'S ARM. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE BROKEN IMPLANT. THIS IS REPORT 6 OF 17 FOR PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14090245 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT AN EMERGENT INCISION AND DRAINAGE AND OPEN REDUCTION INTERNAL FIXATION (ORIF) RIGHT TIBIA DUE TO OSTEOMYELITIS AND INFECTION. ON AN UNKNOWN DATE THE PATIENT FELL WITH HER LEG WENT BEHIND HER, FRACTURING HER TIBIA. SHE ALSO HAD AN OPEN DEHISCENCE OF HER SURGICAL WOUND ON THE KNEE. DUE TO THE BEND OF THE KNEE AND THE SPLIT OF THE SKIN, SHE HAS BEEN BLEEDING AND HAS AN OPENING ON HER KNEE REPLACEMENT. ON (B)(6) 2019 THE PATIENT UNDERWENT AN OPEN TREATMENT OF TIBIAL SHAFT FRACTURE ON THE RIGHT SIDE WITH AN INTERNAL FIXATION WITH PLATE; A SECONDARY CLOSURE OF THE SURGICAL WOUND DEHISCENCE, AND AN EXTENSIVE AND COMPLICATED 8CM AND ARTHROTOMY KNEE WITH EXPLORATION AND DRAINAGE OF THE RIGHT KNEE, WHERE THE KNEE REPLACEMENT IS LOCATED. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 22MM. THIS IS REPORT 6 OF 9 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9649466 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN (B)(6) 2018 THE PATIENT UNDERWENT A REMOVAL SURGERY TO REMOVE THE SYNTHES OLECRANON PLATE DUE TO PAIN AND SYMPTOMATIC HARDWARE. ON (B)(6) 2016, THE PATIENT WAS ASSEMBLING A PARADE FLOAT WHERE SHE WAS KNOCKED OFF BY AN OBJECT AND FELL 5 FEET TO THE GROUND. SHE FELL ON OUTSTRETCHED HANDS AND THEN ONTO HER FACE. SHE REPORTS SIGNIFICANT AMOUNT OF PAIN IN BILATERAL UPPER EXTREMITIES AND LEFT SIDE OF FACE. SHE SUFFERED AN ELBOW FRACTURE THAT REQUIRED SURGERY AND THE PLACEMENT OF A SYNTHES RADIAL HEAD PROSTHESIS SYSTEM IN HER LEFT ELBOW AND SYNTHES OLECRANON LOCKING PLATE AND SCREWS IN HER RIGHT ELBOW. ON (B)(6) 2017, PATIENT'S MAIN COMPLAINT WAS DECREASED LEFT SUPINATION AND ALSO COMPLAINS OF OCCASIONAL POPPING OR MILD CREPITUS ABOUT HER LEFT ELBOW AND FOREARM. THERE WAS ALSO A SUPERFICIAL TENDER NODULE ON HER LEFT MEDIAL ELBOW AND COMPLAINED OF MEDIAL-SIDED ELBOW PAIN. IN REGARDS TO HER RIGHT ELBOW, SHE COMPLAINED OF GLOBAL PAIN AND THE INABILITY TO COMPLETELY EXTEND HER ELBOW. SHE ALSO HAS A PROMINENCE OF THE OLECRANON PLATE. ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL HARDWARE. MULTIPLE STAB WOUNDS WERE MADE ALONG THE COURSE OF THE OLECRANON PLATE AND THE

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8972540 ↗
• 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 8686886 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) 8 HOLE PLATE, FIVE (5) CORTEX SCREWS, TWO (2) CANNULATED SCREWS, AND ONE (1) CANCELLOUS BONE SCREW ON (B)(6) 2017 FOR REPAIR OF A BROKEN RIGHT TIBIA AND FIBULA. SURGERY WAS COMPLETED SUCCESSFULLY. IN (B)(6) 2017, PATIENT REPORTS SKIN ISSUES. IN (B)(6) 2018, PATIENT REPORTS BOTH LEGS FROM KNEE TO FOOT, FOOT AND HANDS, HAD A RASH AND SKIN IRRITATION. PATIENT WAS REFERRED TO A DERMATOLOGIST IN (B)(6) 2018. DERMATOLOGIST DETERMINED PATIENT IS ALLERGIC TO THE IMPLANTED DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW. THIS IS REPORT 2 OF 9 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Skin Irritation

  MAUDE report 8037848 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: 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 22MM. THIS REPORT IS 1 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7975974 ↗