NA 204.838Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982146373), received between Dec 4, 2018 and Sep 15, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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) 3.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 10 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 17755831 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A HARDWARE REMOVAL/REVISION SURGERY DUE TO FEMORAL NONUNION. FROM THE LATERAL SIDE, THE SURGEON REMOVED A VA CONDYLAR PLATE AND CORRESPONDING SCREWS. FROM THE MEDIAL SIDE, THE SURGEON REMOVED A VA PROXIMAL TIBIA PLATE AND CORRESPONDING SCREWS. THE SURGEON THEN ADDRESSED THE NONUNION SITE, AND PLACED 2 NEW PLATES ONTO THE PATIENT'S FEMUR. THREE BROKEN SCREWS FROM THE PRIMARY SURGERY WERE RETAINED IN PATIENT'S FEMUR. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 38MM/. THIS IS REPORT 10 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16897047 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON APRIL 24, 2023, THERE WAS A HARDWARE REMOVAL/REVISION SURGERY DUE TO FEMORAL NONUNION. FROM THE LATERAL SIDE, THE SURGEON REMOVED A VA CONDYLAR PLATE AND CORRESPONDING SCREWS. FROM THE MEDIAL SIDE, THE SURGEON REMOVED A VA PROXIMAL TIBIA PLATE AND CORRESPONDING SCREWS. THE SURGEON THEN ADDRESSED THE NONUNION SITE, AND PLACED 2 NEW PLATES ONTO THE PATIENT'S FEMUR. THREE BROKEN SCREWS FROM THE PRIMARY SURGERY WERE RETAINED IN PATIENT'S FEMUR. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 7 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16897031 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AROUND (B)(6) 2020 THE PATIENT FELL FROM A SCAFFOLDING AND INJURED HIS RIGHT KNEE. THE CT SCAN REVEALED A COMMINUTED BICONDYLAR TIBIAL PLATEAU FRACTURE. AROUND (B)(6) 2020 THE PATIENT UNDERWENT RIGHT TIBIAL ORIF WITH MEDIAL POSTEROMEDIAL PLATING, MEDIAL AND LATERAL MENISCAL REPAIR AND A PROPHYLACTIC 4 COMPARTMENT FASCIOTOMY. THE SURGEON IMPLANTED A PROXIMAL ANTEROLATERAL SYNTHES TIBIAL PLATEAU LOCKING PLATE AND ONE 3.5 POSTEROMEDIAL TIBIAL T PLATE WITH ASSOCIATED SCREWS. THE SURGEON ALSO UTILIZED A SINGLE-USE DRILL BIT. FOLLOWING THE SURGERY OF (B)(6) 2020 THE PATIENT PERFORMED REHABILITATION AND THERAPY AS RECOMMENDED BY HIS MEDICAL PROVIDERS. HOWEVER, HE CONTINUED TO EXPERIENCE PAIN, DISCOMFORT, AND FUNCTIONAL LIMITATIONS IN HIS RIGHT KNEE. ALSO HE EXPERIENCED PROBLEMS WITH WOUND HEALING, INCLUDING INCREASED PAIN, SWELLING, AND DRAINAGE FROM THE INCISION SITE. AROUND (B)(6) 2020 THE PATIENT DIAGNOSED WITH SEPTIC ARTHRITIS. IT WAS DETERMINED THAT THE PATIENT WOULD UNDERGO ADDITIONAL SURGERY FOR HIS WOUND COMPLICATIONS, INCLUDING ARTHROSCOPIC IRRIGATION AND DEBRIDEMENT OF HIS MEDIAL AND LATERAL INCISIONS ALONG WITH THE REMOVAL OF ALL HIS HARDWARE AND THE INSTAL

  Patient problems: Discomfort; Impaired Healing; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16753133 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS REMOVAL OF HARDWARE DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1)3.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15177163 ↗
• InjurySep 9, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, A CORTICAL SCREW BROKE OFF IN THE PATIENT. THE CORTICAL SCREW WAS USED FOR COMPRESSION IN THE PLATE. THE THREAD OF THE SCREW IS STILL IN THE PATIENT THE SURGEON CONCERN ABOUT TAKING IT OUT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12447431 ↗
• 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 8193036 ↗
• 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 NOVEMBER 27, 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 WA

  Patient problems: Unspecified Infection

  MAUDE report 8193035 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018, DUE TO A NONUNION AND HARDWARE FAILURE. THE PATIENT INITIALLY HAD AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY ON (B)(6) 2018, TO TREAT A LEFT DISTAL HUMERUS FRACTURE. THE IMPLANTED DEVICES WERE THE FOLLOWING VARIABLE ANGLE DISTAL HUMERUS, VARIABLE ANGLE-LCP LATERAL DISTAL HUMERUS, EIGHT (8) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE, VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE, VARIABLE ANGLE-LCP PROXIMAL OLECRANON, AND FOUR (4) CORTEX SCREW SELF- TAPPING. DURING THE PROCEDURE, ALL HARDWARE WAS REMOVED AND WAS INTACT. THERE WAS NO COMPLICATIONS OR EXTENDED TIME NEEDED. THE FRACTURE WAS REDUCED AND AN UNKNOWN VARIABLE ANGLE ELBOW PLATES AND UNKNOWN SCREWS WERE USED FOR FIXATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS STABLE. THERE WERE NO X-RAYS ARE AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8128483 ↗