NA 204.832Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982146342), received between Dec 4, 2018 and Sep 15, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjurySep 15, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT HAD CAR/CAR COLLISION AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT UNDERWENT SEVERAL SURGERIES FOR ORTHOPEDIC INJURIES INCLUDING AN OPEN REDUCTION INTERNAL FIXATION FOR A FRACTURE-DISLOCATION OF HIS FEMORAL HEAD AND NECK AND A SACROILIAC SCREW FIXATION AND ANTERIOR PUBIC PLATE FOR MALGAIGNE FRACTURE. ON (B)(6) 2008 THE PATIENT UNDERWENT ORIF LEFT FEMORAL HEAD, ORIF LEFT FEMORAL NECK, ORIF LEFT ANTERIOR COLUMN ACETABULUM, ORIF PUBIC SYMPHYSIS (SYNTHES PELVIC PLATE ACROSS HIS PUBIS EXTENDING TO THE LEFT HIP) AND PERCUTANEOUS ILIOSACRAL SCREW FIXATION DUE TO LEFT ACETABULAR FRACTURE AND LEFT FEMORAL HEAD FRACTURE. ON (B)(6) 2010 THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY WITH DEPUY COMPONENTS DUE TO HIP PAIN, METALLOSIS, TRAUMATIC ARTHRITIS LEFT HIP WITH FEMORAL HEAD AVASCULAR NECROSIS AND NONUNION FEMORAL HEAD FRACTURE, MALGAIGNE FRACTURE AND INTRAARTICULAR HARDWARE BROKE WITH SCREWS. THIS REPORT INVOLVES ONE (1) .5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 9 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4). (B)(4) CAPTURES ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT.

  Patient problems: Foreign Body Reaction; Necrosis; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 17755764 ↗
• InjuryFeb 1, 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 A HARDWARE REMOVAL WITH 3.5 LCP METAPHYSEAL PLATE AND 3.5 CORTEX SCREWS IN QUESTION. THE PATIENT HAD AN INITIAL PROCEDURE PERFORMED AT AN OUTSIDE HOSPITAL BACK IN (B)(6) OF 2020 FOR A HUMERUS NON-UNION. THE PATIENT RESIDES AT A NURSING HOME AND WAS LOST TO FOLLOW UP DUE TO COVID RESTRICTIONS. THE PATIENT WAS TRANSFERRED TO A SURGEON ON (B)(6) 2021 AND UPON LABORATORY DIAGNOSIS WAS DETERMINED TO HAVE AN INFECTION AND THE HARDWARE WAS REMOVED WITHOUT ISSUE ON (B)(6) 2021. THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 32MM. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11261821 ↗
• 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 28MM. THIS REPORT IS 8 OF 10 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11132581 ↗
• InjuryDec 22, 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 OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE DUE TO AN INJURY. THE OPEN DISTAL TIBIA FRACTURE WAS PLATED WITH ONE (1) MEDIAL DISTAL TIBIA PLATE AND ONE (1) LOCKING COMPRESSION (LCP) PLATE. THE FIBULA WAS ALSO PLATED WITH ONE (1) ONE-THIRD (1/3) TUBULAR PLATE. THE PATIENT HAD AN INFECTION DUE TO THE OPEN FRACTURE AND WAS MADE AWARE ON (B)(6) 2018. A HARDWARE REMOVAL WAS CONDUCTED ON (B)(6) 2018 FOR ALL PLATES INCLUDING ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 50MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 42MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE (TM) RECESS 40MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE (TM) RECESS 18MM, TWO (2) 2.7MM CORTEX SCREW SELF-TAPPING 32MM, ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 36MM, TWO (2) 3.5MM CORTEX SCREW SELF-TAPPING 38MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 36MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 34MM, FIVE (5) 3.5MM CORTEX SCREW SELF-TAPPING 32MM, AND ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 30MM. IRRIGATION AND DEBRIDEMENT WAS PERFORMED

  Patient problems: Unspecified Infection

  MAUDE report 8193047 ↗
• InjuryDec 22, 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 OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE DUE TO AN INJURY. THE OPEN DISTAL TIBIA FRACTURE WAS PLATED WITH ONE (1) MEDIAL DISTAL TIBIA PLATE AND ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE. THE FIBULA WAS ALSO PLATED WITH ONE (1) ONE-THIRD (1/3) TUBULAR PLATE. THE PATIENT HAD AN INFECTION DUE TO THE OPEN FRACTURE AND WAS MADE AWARE ON (B)(6) 2018. A HARDWARE REMOVAL WAS CONDUCTED ON (B)(6) 2018 FOR ALL PLATES INCLUDING ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 50MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 42MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 40MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 18MM, TWO (2) 2.7MM CORTEX SCREW SELF-TAPPING 32MM, ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 36MM, TWO (2) 3.5MM CORTEX SCREW SELF-TAPPING 38MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 36MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 34MM, FIVE (5) 3.5MM CORTEX SCREW SELF-TAPPING 32MM, AND ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 30MM. IRRIGATION AND DEBRIDEMENT WAS PERFO

  Patient problems: Unspecified Infection

  MAUDE report 8193046 ↗
• InjuryDec 22, 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 OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE DUE TO AN INJURY. THE OPEN DISTAL TIBIA FRACTURE WAS PLATED WITH ONE (1) MEDIAL DISTAL TIBIA PLATE AND ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE. THE FIBULA WAS ALSO PLATED WITH ONE (1) ONE-THIRD (1/3) TUBULAR PLATE. THE PATIENT HAD AN INFECTION DUE TO THE OPEN FRACTURE AND WAS MADE AWARE ON (B)(6) 2018. A HARDWARE REMOVAL WAS CONDUCTED ON (B)(6) 2018 FOR ALL PLATES INCLUDING ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE (TM) RECESS 50MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 42MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 40MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 18MM, TWO (2) 2.7MM CORTEX SCREW SELF-TAPPING 32MM, ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 36MM, TWO (2) 3.5MM CORTEX SCREW SELF-TAPPING 38MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 36MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 34MM, FIVE (5) 3.5MM CORTEX SCREW SELF-TAPPING 32MM, AND ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 30MM. IRRIGATION AND DEBRIDEMENT WAS PERF

  Patient problems: Unspecified Infection

  MAUDE report 8193045 ↗
• InjuryDec 22, 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 OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE DUE TO AN INJURY. THE OPEN DISTAL TIBIA FRACTURE WAS PLATED WITH ONE (1) MEDIAL DISTAL TIBIA PLATE AND ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE. THE FIBULA WAS ALSO PLATED WITH ONE (1) ONE-THIRD (1/3) TUBULAR PLATE. THE PATIENT HAD AN INFECTION DUE TO THE OPEN FRACTURE AND WAS MADE AWARE ON (B)(6) 2018. A HARDWARE REMOVAL WAS CONDUCTED ON (B)(6) 2018 FOR ALL PLATES INCLUDING ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 50MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 42MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 40MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 18MM, TWO (2) 2.7MM CORTEX SCREW SELF-TAPPING 32MM, ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 36MM, TWO (2) 3.5MM CORTEX SCREW SELF-TAPPING 38MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 36MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 34MM, FIVE (5) 3.5MM CORTEX SCREW SELF-TAPPING 32MM, AND ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 30MM. IRRIGATION AND DEBRIDEMENT WAS PERFO

  Patient problems: Unspecified Infection

  MAUDE report 8193043 ↗
• InjuryDec 22, 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 OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE DUE TO AN INJURY. THE OPEN DISTAL TIBIA FRACTURE WAS PLATED WITH ONE (1) MEDIAL DISTAL TIBIA PLATE AND ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE. THE FIBULA WAS ALSO PLATED WITH ONE (1) ONE-THIRD (1/3) TUBULAR PLATE. THE PATIENT HAD AN INFECTION DUE TO THE OPEN FRACTURE AND WAS MADE AWARE ON (B)(6). A HARDWARE REMOVAL WAS CONDUCTED ON (B)(6) 2018 FOR ALL PLATES INCLUDING ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 50MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 42MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 40MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 18MM, TWO (2) 2.7MM CORTEX SCREW SELF-TAPPING 32MM, ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 36MM, TWO (2) 3.5MM CORTEX SCREW SELF-TAPPING 38MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 36MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 34MM, FIVE (5) 3.5MM CORTEX SCREW SELF-TAPPING 32MM, AND ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 30MM. IRRIGATION AND DEBRIDEMENT WAS PERFORMED

  Patient problems: Unspecified Infection

  MAUDE report 8193042 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT NOT ALL THE DEVICES WERE REMOVED. IT IS UNKNOWN WHICH SPECIFIC DEVICES WERE REMOVED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8128449 ↗