NA 214.836Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982154675), received between Mar 9, 2018 and Feb 10, 2025 — classified as 20 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE WHILE COMPRESSING A VA CONDYLAR PLATE TO BONE WITH 4.5 CORTEX SCREWS, DR. HAD ONE SCREW AROUND HALF IMPLANTED AND AS HE FULLY IMPLANTED A 2ND SCREW, THE FIRST SCREW BROKE. THERE WAS A 2 MINUTE SURGICAL DELAYED DUE TO THE REPORTED EVENT. THE BROKEN SCREW WAS REMOVED WITH HEMOSTATS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21347489 ↗
• MalfunctionMay 16, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 HEAD OF A 4.5MM CORTEX SCREW BROKE OFF WHILE SURGEON WAS TIGHTENING IT DOWN. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939936 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE MEDICAL RECORDS RECEIVED ON FEBRUARY 25, 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) DISTAL FEMUR FRACTURE DUE TO RIGHT PERIPROSTHETIC DISTAL FEMUR FRACTURE. ON (B)(6) 2022 ,THE PATIENT HAD A REVISION DUE TO NONUNION RIGHT DISTAL FEMUR SHAFT FRACTURE ABOUT TOTAL KNEE ARTHROPLASTY (TKA). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS IS REPORT 11 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16718098 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE MEDICAL RECORDS RECEIVED ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) DISTAL FEMUR FRACTURE DUE TO RIGHT PERIPROSTHETIC DISTAL FEMUR FRACTURE. ON (B)(6) 2022 THE PATIENT HAD A REVISION DUE TO NONUNION RIGHT DISTAL FEMUR SHAFT FRACTURE ABOUT TOTAL KNEE ARTHROPLASTY (TKA). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS IS REPORT 6 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16718019 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 ALL IMPLANTS REMOVED WITHOUT INCIDENT. PATIENT WAS INFECTED. CLEAN OUT CANAL THROUGH REAMING AND IRRIGATION. IMPLANT OF AN ANTIBIOTIC COATED NAIL. NO IMPLANTS TO BE RETURNED. THIS REPORT IS FOR ONE (1)4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS IS REPORT 9 OF 11 FOR COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 15429864 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE CORTEX SCREWS SELF TAPPING HEAD BROKE OFF DURING INSERTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13215276 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF HARDWARE AND REVISION OF OPEN REDUCTION INTERNAL FIXATION(ORIF) LEFT FEMUR DUE TO FAILED FIXATION. LEFT HIP, FAILED DHS CONSTRUCT FOR SUBTROCH PROXIMAL FEMUR FRACTURE. THE ORIGINAL SURGERY WAS ON (B)(6) 2021. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

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

  MAUDE report 12902905 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF HARDWARE AND REVISION OF OPEN REDUCTION INTERNAL FIXATION(ORIF) LEFT FEMUR DUE TO FAILED FIXATION. LEFT HIP, FAILED DHS CONSTRUCT FOR SUBTROCH PROXIMAL FEMUR FRACTURE. THE ORIGINAL SURGERY WAS ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 4 OF 7 FOR (B)(4).

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

  MAUDE report 12902740 ↗
• InjuryNov 10, 2021Adverse 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 UNDERWENT FOR A SURGERY. DURING A SURGERY, THERE WAS A REVISION FIXATION DUE TO FRACTURE DISTAL TO HARDWARE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12788110 ↗
• InjuryJun 24, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A ORIF DISTAL FEMUR PROCEDURE. IT WAS NOTED THAT THE PLATE BROKE AT HOLE NUMBER 8 AND ALSO THE 3 - 4.5MM CORTICAL SCREWS BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THE PROCEDURE IS COMPLETED. NO PATIENT CONSEQUENCES NOTED. DEVICES WERE INVOLVED: 214.836 (4.5MM CORTEX SCREW SELF-TAPPING 36MM); QUANTITY: 3; 02.231.275 (5.0 VA LOCKNG SCR SLF-TPNG/SD/75); QUANTITY: 5-6; A PLATE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS REPORT IS 5 OF 10 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12063865 ↗
• InjuryJun 24, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A ORIF DISTAL FEMUR PROCEDURE. IT WAS NOTED THAT THE PLATE BROKE AT HOLE NUMBER 8 AND ALSO THE 3 - 4.5MM CORTICAL SCREWS BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THE PROCEDURE IS COMPLETED. NO PATIENT CONSEQUENCES NOTED. DEVICES WERE INVOLVED: 214.836 (4.5MM CORTEX SCREW SELF-TAPPING 36MM), QUANTITY: 3, 02.231.275 (5.0 VA LOCKNG SCR SLF-TPNG/SD/75), QUANTITY: 5-6 AND A PLATE. THIS COMPLAINT INVOLVES (10) DEVICES. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS REPORT IS 6 OF 10 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12063863 ↗
• InjuryJun 24, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A ORIF DISTAL FEMUR PROCEDURE. IT WAS NOTED THAT THE PLATE BROKE AT HOLE NUMBER 8 AND ALSO THE 3 - 4.5MM CORTICAL SCREWS BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THE PROCEDURE IS COMPLETED. NO PATIENT CONSEQUENCES NOTED. DEVICES WERE INVOLVED: 214.836 (4.5MM CORTEX SCREW SELF-TAPPING 36MM); QUANTITY: 3; 02.231.275 (5.0 VA LOCKNG SCR SLF-TPNG/SD/75); QUANTITY: 5-6; A PLATE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS REPORT IS 4 OF 10 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12063857 ↗
• InjuryJun 24, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A ORIF DISTAL FEMUR PROCEDURE. IT WAS NOTED THAT THE PLATE BROKE AT HOLE NUMBER 8 AND ALSO THE 3 - 4.5MM CORTICAL SCREWS BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THE PROCEDURE IS COMPLETED. NO PATIENT CONSEQUENCES NOTED. DEVICES WERE INVOLVED: 214.836 (4.5MM CORTEX SCREW SELF-TAPPING 36MM), QUANTITY: 3, 02.231.275 (5.0 VA LOCKNG SCR SLF-TPNG/SD/75), QUANTITY: 5-6, A PLATE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS REPORT IS 3 OF 10 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12063850 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO BONE HEALING. THE DOCTOR SCHEDULED A REMOVAL OF AN ANGLED BLADE PLATE AND THE PATIENT HAD A PROXIMAL FEMUR CORRECTION ON A PREVIOUS DATE. PATIENT WAS HEALED AND NO LONGER NEEDED THE IMPLANTED HARDWARE. REMOVAL WAS VERY UNEVENTFUL AND HAD NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

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

  MAUDE report 11837821 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO BONE HEALING. THE DOCTOR SCHEDULED A REMOVAL OF AN ANGLED BLADE PLAE AND THE PATIENT HAD A PROXIMAL FEMUR CORRECTION ON A PREVIOUS DATE. PATIENT WAS HEALED AND NO LONGER NEEDED THE IMPLANTED HARDWARE. REMOVAL WAS VERY UNEVENTFUL AND HAD NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

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

  MAUDE report 11836609 ↗
• MalfunctionMar 20, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROXIMAL FEMUR FRACTURE FIXATION PROCEDURE WITH 95 DEGREE CONDYLAR BLADE PLATE ON (B)(6) 2019. UPON INSERTION OF THE CORTEX SCREW SELF-TAPPING, THE HEAD BROKE OFF. THE SURGEON REMOVED THE BROKEN HEAD EASILY AND THE SHAFT OF THE SCREW WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - CONDYLAR PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8437146 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF HARDWARE ON (B)(6) 2018 DUE TO INFECTION CAUSED BY THE FEMUR IMPLANTS AND PAIN CAUSED BY THE TIBIAL IMPLANTS. IMPLANTS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. DEVICES REMOVED ARE ONE (1) TITANIUM CANNULATED TIBIAL NAIL, ONE (1) TITANIUM END CAP, TWO (2) TITANIUM LOCKING SCREW, ONE (1) LOCKING COMPRESSION (LCP) CURVED CONDYLAR PLATE, ONE (1) PERIPROSTHETIC LOCKING SCREW, ONE (1) LOCKING SCREW, EIGHT (8) CORTEX SCREWS, AND TWO (2) CANNULATED SCREW PARTIALLY THREADED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL 17 DEVICES. COMPLAINT (B)(4) CAPTURES 10 DEVICES. THE REMAINING 7 DEVICES HAVE BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7679820 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF HARDWARE ON (B)(6) 2018 DUE TO INFECTION CAUSED BY THE FEMUR IMPLANTS AND PAIN CAUSED BY THE TIBIAL IMPLANTS. IMPLANTS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. DEVICES REMOVED ARE ONE (1) TITANIUM CANNULATED TIBIAL NAIL, ONE (1) TITANIUM END CAP, TWO (2) TITANIUM LOCKING SCREW, ONE (1) LOCKING COMPRESSION (LCP) CURVED CONDYLAR PLATE, ONE (1) PERIPROSTHETIC LOCKING SCREW, ONE (1) LOCKING SCREW, EIGHT (8) CORTEX SCREWS, AND TWO (2) CANNULATED SCREW PARTIALLY THREADED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL 17 DEVICES. COMPLAINT (B)(4) CAPTURES 10 DEVICES. THE REMAINING 7 DEVICES HAVE BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 36MM. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7679798 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS REPORT CAPTURES ONE 4.5 MM CORTEX SCREW SELF-TAPPING 36 MM. THIS IS REPORT 1 OF 10 FOR (B)(4). THE OTHER SCREW IS BEING CAPTURED ON RELATED (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7497928 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR USING SYNTHES VA CONDYLAR PLATE AND SCREWS. THE OUTCOME OF THE SURGERY WAS A NONUNION. ON (B)(6) 2018 THE SURGEON PERFORMED A REVISION ORIF OF THE DISTAL FEMUR TO ADDRESS THE NONUNION. THE PLATES AND SCREWS WERE INTACT AND SUCCESSFULLY REMOVED. A BONE GRAFT WAS INSERTED AND A NEW SYNTHES VA CONDYLAR PLATE AND SCREWS WERE INSERTED IN THE PATIENT. THE REVISION WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THIS IS REPORT 3 OF 8 (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7406831 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A PARTIAL REVISION OF TOTAL KNEE AND KNEE MANIPULATION, AND WAS IMPLANTED WITH A 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE, FOUR (4) 4.5MM CORTEX SCREWS, THREE (3) CANNULATED VA LOCKING SCREWS, AND TWO (2) 5.0MM CANNULATED VA LOCKING SCREWS ON UNKNOWN DATE IN 2016. ON UNKNOWN DATE PATIENT REPORTED PAIN AND STIFFNESS ASSOCIATED WITH THE IMPLANTS. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS NOT REVISED TO ANY ADDITIONAL HARDWARE AS THE FRACTURE HAD HEALED. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW 36MM. (B)(4).

  Patient problems: Pain

  MAUDE report 7328327 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A PARTIAL REVISION OF TOTAL KNEE AND KNEE MANIPULATION, AND WAS IMPLANTED WITH A 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE, FOUR (4) 4.5MM CORTEX SCREWS, THREE (3) CANNULATED VA LOCKING SCREWS, AND TWO (2) 5.0MM CANNULATED VA LOCKING SCREWS ON UNKNOWN DATE IN 2016. ON UNKNOWN DATE PATIENT REPORTED PAIN AND STIFFNESS ASSOCIATED WITH THE IMPLANTS. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS NOT REVISED TO ANY ADDITIONAL HARDWARE AS THE FRACTURE HAD HEALED. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW 36MM. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7328293 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A PARTIAL REVISION OF TOTAL KNEE AND KNEE MANIPULATION, AND WAS IMPLANTED WITH A 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE, FOUR (4) 4.5MM CORTEX SCREWS, THREE (3) CANNULATED VA LOCKING SCREWS, AND TWO (2) 5.0MM CANNULATED VA LOCKING SCREWS ON UNKNOWN DATE IN 2016. ON UNKNOWN DATE PATIENT REPORTED PAIN AND STIFFNESS ASSOCIATED WITH THE IMPLANTS. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS NOT REVISED TO ANY ADDITIONAL HARDWARE AS THE FRACTURE HAD HEALED. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW 36MM. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7328138 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A PARTIAL REVISION OF TOTAL KNEE AND KNEE MANIPULATION, AND WAS IMPLANTED WITH A 4.5 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE, FOUR (4) 4.5 MM CORTEX SCREWS, THREE (3) CANNULATED VA LOCKING SCREWS, AND TWO (2) 5.0 MM CANNULATED VA LOCKING SCREWS ON UNKNOWN DATE IN 2016. ON UNKNOWN DATE PATIENT REPORTED PAIN AND STIFFNESS ASSOCIATED WITH THE IMPLANTS. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS NOT REVISED TO ANY ADDITIONAL HARDWARE AS THE FRACTURE HAD HEALED. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 4.5 MM CORTEX SCREW 36 MM. THIS IS REPORT 2 OF 10 FOR PC-(B)(4).

  Patient problems: Pain

  MAUDE report 7328059 ↗