NA 214.834Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982154668), received between May 4, 2018 and Apr 11, 2023 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 34MM. THIS IS REPORT 5 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16717989 ↗
• InjurySep 27, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS REVISION OF SCREWS DUE TO BROKEN SCREW OF POSSIBLE INFECTION/ NONUNION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. FRAGMENTS WERE GENERATED AND WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. PATIENT STATUS/ OUTCOME: UNKNOWN. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 34MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 15491748 ↗
• InjuryAug 4, 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 REMOVAL OF HARDWARE DUE TO PAIN. REMOVAL OF THREE CORTEX SCREWS AND THREE LOCKING SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 34MM. THIS REPORT IS 4 OF 6 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12277964 ↗
• InjuryAug 4, 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 REMOVAL OF HARDWARE DUE TO PAIN. REMOVAL OF THREE CORTEX SCREWS AND THREE LOCKING SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 34MM. THIS REPORT IS 3 OF 6 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12277957 ↗
• InjuryAug 4, 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 REMOVAL OF HARDWARE DUE TO PAIN. REMOVAL OF THREE CORTEX SCREWS AND THREE LOCKING SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 34MM. THIS REPORT IS 1 OF 6 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12277953 ↗
• InjuryMar 4, 2019Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT EXTRACTION LOCKING COMPRESSION PLATE (LCP) 4.5 DUE TO SCREW RUPTURE AND FAILURE. THE SURGEON REMOVED SOME BROKEN ONE (1) 4.5/32 MM CORTEX SCREW SELF-TAPING AND ONE (1) 4.5/34 MM CORTEX SCREW SELF-TAPPING FROM THE LCP PLATE. THE PLATE WAS INTACT, AND TWO NEW SCREWS WERE REPLACED BY A CABLE SYSTEM. THE PATIENT EXPERIENCED PAIN AND INSTABILITY TOWARDS THE BROKEN SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. PATIENT OUTCOME WAS OKAY. CONCOMITANT DEVICES: LOCKING COMPRESSION PLATE (PART/LOT UNKNOWN, QUANTITY 1); SCREWS (PART/LOT UNKNOWN, QUANTITY 5). THIS REPORT IS FOR A CORTEX SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 8387324 ↗
• MalfunctionDec 6, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN UNKNOWN SURGERY. THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE WAS ATTACHED TO AN AIMING ARM. WHILE THE SURGEON WAS ATTEMPTING TO ATTACH PERCUTANEOUS TROCAR TO THE JIG, THE AIMING ARM FELL OFF THE PLATE. THIS OCCURRED A FEW TIMES DURING THE CASE UNTIL THE JIG WAS NO LONGER ABLE TO GRAB THE PLATE; PRESUMABLY THE HOLE IN THE PLATE WAS STRIPPED OUT. UPON PULLING THE PLATE, THE HEAD OF A CORTEX SCREW SELF-TAPPING BROKE OFF. THEY WERE ABLE TO RETRIEVE THE SCREW FRAGMENT IN THE MEDULLARY CANAL WITH SOME DIFFICULTY. A NEW, LONGER PLATE WAS PLACED AND NO OTHER PROBLEMS OCCURRED. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: TROCAR INSTRUMENT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), INSERTION HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), AIMING ARM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 4.5MM CORTEX SCREW SELF-TAPPING 34MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8139338 ↗
• 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)(6) CAPTURES 10 DEVICES. THE REMAINING 7 DEVICES HAVE BEEN CAPTURED UNDER LINKED COMPLAINT (B)(6). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 34MM. THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(6).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7679773 ↗
• 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) 4.5 MM CORTEX SCREW SELF-TAPPING 34 MM THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7679765 ↗
• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ORIGINAL OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PERIPROSTHETIC FRACTURE OF TOTAL HIP STEM ON (B)(6) 2018. A LONG BROAD CURVED PLATE WAS USED WITH CABLES TO FIX THE FRACTURE. PATIENT LATER SUFFERED A NEW FRACTURE DISTAL TO THE PLATE AND THE SURGEON REVISED THE ORIGINAL PLATE BY REMOVING IT AND REPLACING IT WITH A 4.5 VA-LCP CURVED CONDYLAR PLATE AND CABLES ON (B)(6) 2018. THE ORIGINAL CONSTRUCT DID NOT FAIL. IT WAS REMOVED TO REVISE TO A NEW PLATE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT DISPOSITION IS UNKNOWN. THIS REPORT IS FOR A 4.5 MM CORTEX SCREW SELF-TAPPING 34 MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 7487834 ↗