NA 204.850Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982146441), received between Jan 2, 2018 and Oct 4, 2023 — classified as 10 injuries, 1 malfunction.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM INDIA REPORTS AN EVENT AS FOLLOWS: ON (B)(6), 2022 THE PATIENT MET WITH A ROAD TRAFFIC ACCIDENT THROUGH BIKE AND SUSTAINED INJURIES, HEAD AND PELVIC FRACTURE. THE INJURIES ARE LIKE HEAD INJURY, DIFFUSE TRAUMATIC SUBARACHNOID HEMORRHAGE, LEFT ORBITAL WALL FRACTURE AND PATELLA/LEFT HIP FRACTURE. ON (B)(6), 2022 THE PATIENT UNDERWENT (1ST COMPONENT) OPEN REDUCTION & INTERNAL FIXATION WITH TENSION BOND WIRING FOR LEFT PATELLA. (2ND COMPONENT) ORIF RECON PLATE FOR ANTERIOR COLUMN LEFT ACETABULUM. (3RD COMPONENT) ORIF WITH RECON PLATE POSTERIOR COLUMN LEFT ACETABULUM. ON (B)(6), 2022 THE DISTAL FEMUR PIN APPLIED DUE TO THE SURGEON DID NOT PROPERLY USED THE C-ARM AND IGNORE THE COMPONENT LEFT PATELLA WHICH LED TO THE IMPLANT GOT FAILED DUE TO DISCREPANCY REDUCTION AND USING PINS FOR TEMPORARY SOLUTION/TREATMENT. ON (B)(6), 2022 LEFT FRONTAL BURR HOLE EVACUATION OF SUBDURAL COLLECTION & PLACEMENT OF SUBDURAL RESERVOIR. ON (B)(6), 2022 THE PATIENT UNDERWENT (2ND COMPONENT OF 1ST SURGERY) REVISION ACETABULUM WITH AO POSTERIOR PLATE. ANTERIOR QUADRILATERAL PLATE AND AO BUTTRESS PLATE (RE-DO OF 3RD ITEM OF THE 1ST SURGERY DUE TO THE FRACTURE REDUCTION GOT FAILED WITH A STIFF

  Patient problems: Deformity/ Disfigurement; Muscular Rigidity

  MAUDE report 17868984 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM INDIA REPORTS AN EVENT AS FOLLOWS: ON (B)(6) 2022 THE PATIENT MET WITH A ROAD TRAFFIC ACCIDENT THROUGH BIKE AND SUSTAINED INJURIES, HEAD AND PELVIC FRACTURE. THE INJURIES ARE LIKE HEAD INJURY, DIFFUSE TRAUMATIC SUBARACHNOID HEMORRHAGE, LEFT ORBITAL WALL FRACTURE AND PATELLA/LEFT HIP FRACTURE. ON (B)(6) 2022 THE PATIENT UNDERWENT (1ST COMPONENT) OPEN REDUCTION & INTERNAL FIXATION WITH TENSION BOND WIRING FOR LEFT PATELLA. (2ND COMPONENT) ORIF RECON PLATE FOR ANTERIOR COLUMN LEFT ACETABULUM. (3RD COMPONENT) ORIF WITH RECON PLATE POSTERIOR COLUMN LEFT ACETABULUM. ON (B)(6) 2022 THE DISTAL FEMUR PIN APPLIED DUE TO THE SURGEON DID NOT PROPERLY USED THE C-ARM AND IGNORE THE COMPONENT LEFT PATELLA WHICH LED TO THE IMPLANT GOT FAILED DUE TO DISCREPANCY REDUCTION AND USING PINS FOR TEMPORARY SOLUTION/TREATMENT. ON (B)(6) 2022 LEFT FRONTAL BURR HOLE EVACUATION OF SUBDURAL COLLECTION & PLACEMENT OF SUBDURAL RESERVOIR. ON (B)(6) 2022 THE PATIENT UNDERWENT (2ND COMPONENT OF 1ST SURGERY) REVISION ACETABULUM WITH AO POSTERIOR PLATE. ANTERIOR QUADRILATERAL PLATE AND AO BUTTRESS PLATE (RE-DO OF 3RD ITEM OF THE 1ST SURGERY DUE TO THE FRACTURE REDUCTION GOT FAILED WITH A STIFFNESS

  Patient problems: Deformity/ Disfigurement; Muscular Rigidity

  MAUDE report 17863703 ↗
• InjurySep 14, 2023Break; Break

  IT WAS REPORTED THAT IN (B)(6) 2008, THE PATIENT HAD A CAR COLLISION AND WAS ADMITTED TO THE HOSPITAL. HE 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 A 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. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM CORTEX SCREW SELF-TAPPING 50MM. THIS IS REPORT 10 OF 10 FOR (B)(4).

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

  MAUDE report 17746299 ↗
• 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 16753301 ↗
• 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 16751401 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS SUBMITTED AS PART OF AN INVESTIGATOR INITIATED STUDY (IIS) FOR THE RETROGRADE FEMORAL NAIL ADVANCED (RFNA). IT WAS REPORTED THAT A PATIENT WAS PRESENTED AFTER A MOTOR VEHICLE CRASH WITH A LEFT OPEN DISTAL FEMUR FRACTURE ON (B)(6) 2021 AND WAS OPERATED ON WITH RFNA INTRAMEDULLARY NAIL ON (B)(6) 2021. PATIENT WAS DIAGNOSED WITH INFECTION OF HER HARDWARE/SEPTIC NONUNION ON (B)(6) 2021. PATIENT UNDERWENT DEBRIDEMENT AND EXCHANGE OF HARDWARE ON (B)(6) 2021. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 50MM THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).

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

  MAUDE report 15643858 ↗
• InjurySep 6, 2019Adverse 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 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) 2018, THE PATIENT UNDERWENT REMOVAL HARDWARE. MULTIPLE STAB WOUNDS WERE MADE ALONG THE COURSE OF THE OLECRANON PLATE AND THE SCREWS WERE REMOVED. ONCE THE SCREWS WERE REMOVED FROM THE OLECRANON PLATE, WE WERE ABLE TO PASS IN AN ELEVATOR AND LOOSEN THE PLATE OFF THE BACK OF THE OLECRANON. THE PLATE WAS THEN FED OUT THROUGH ONE OF THE INCISIONS AND WE WERE ABLE TO REMOVE THE WHOLE PLATE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 50MM. THIS REPORT IS 4 OF 6 FOR (B)(4).

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

  MAUDE report 8972543 ↗
• MalfunctionSep 25, 2018Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT A CORTEX SCREW BROKE DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018. THE HEAD PORTION OF THE CORTEX SCREW WAS REMOVED AND THE TIP OF THE SCREW WAS LEFT IN THE TIBIA PER THE SURGEON'S DECISION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT HARM REPORTED AND THE OUTCOME OF THE CASE WAS NOT IMPACTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7905846 ↗
• InjuryFeb 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LEGAL DEPARTMENT REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT ON (B)(6) 2013 (APPROXIMATE DATE), PATIENT ASSISTED A FRIEND BY LOADING A MOTORCYCLE ON TO A TRAILER WHEN THE MOTORCYCLE FELL ONTO HIS LOWER RIGHT LEG. PATIENT SUSTAINED A DISTAL TIBIA AND FIBULA FRACTURE ABOVE THE RIGHT ANKLE. PATIENT UNDERWENT SURGERY ON (B)(6) 2013 (APPROXIMATE DATE) TO IMMOBILIZE THE LOWER RIGHT LEG/ANKLE FOR THE HEALING PROCESS AND WAS IMPLANTED WITH SYNTHES LOCKING SMALL FRAGMENT SET WHICH CONSISTED OF PLATES AND SCREWS. IN (B)(6) OF 2015 PATIENT NOTICED PAIN AND SWELLING AND A CURVATURE THAT BEGAN TO DEVELOP IN HIS LOWER RIGHT LEG/ANKLE AND WENT TO THE EMERGENCY ROOM IN (B)(6) OF 2015 AT ONE HOSPITAL AND THEN TO ANOTHER HOSPITAL DUE TO THE PAIN AND THE DEFORMITY DEVELOPING IN HIS LOWER RIGHT LEG/ANKLE. X-RAYS TAKEN ON (B)(6) 2015 (APPROXIMATE DATE) AND AGAIN ON (B)(6) 2015 (APPROXIMATE DATE) REVEALING A CURVATURE/DEFORMITY. IT WAS NOTED THAT THE PLATE WAS BROKEN ALONG WITH MANY OF THE SCREWS AND THERE WAS A NONUNION OF THE TIBIA AND FIBULA FRACTURES. AFTER THE EMERGENCY ROOM VISIT, PATIENT WENT TO A MEDICAL CENTER FOR FURTHER EVALUATION. PATIENT WAS INFORMED ABOUT UNDERGOING REVISION SUR

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7295079 ↗
• InjuryJan 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF ANKLE AND CALCANEUS DONE ON (B)(6) 2017. AFTER SOME TIME THE TALUS FELL INTO A TILT BECAUSE OF AN OVER-REDUCTION OF SYNDESMOSIS. SO A REVISION SURGERY WAS PERFORMED AND TWO 3.5MM CORTEX SCREWS AND TWO 4.0MM CANNULATED SCREWS WERE REMOVED. THE FIBULA WAS RE-REDUCED AND TWO 3.5MM CORTICAL SYNDESMOSIS SCREWS WERE PLACED IN THE LAST TWO HOLES. AN ACUMED MEDIAL HOOK PLATE WAS PLACED ON THE MEDIAL MALLEOLUS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH STABLE PATIENT OUTCOME AND NO SURGICAL DELAY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR A CORTEX SCREW. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7158608 ↗
• InjuryJan 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF ANKLE AND CALCANEUS DONE ON (B)(6) 2017. AFTER SOME TIME THE TALUS FELL INTO A TILT BECAUSE OF AN OVER-REDUCTION OF SYNDESMOSIS. SO A REVISION SURGERY WAS PERFORMED AND TWO 3.5MM CORTEX SCREWS AND TWO 4.0MM CANNULATED SCREWS WERE REMOVED. THE FIBULA WAS RE-REDUCED AND TWO 3.5MM CORTICAL SYNDESMOSIS SCREWS WERE PLACED IN THE LAST TWO HOLES. AN ACUMED MEDIAL HOOK PLATE WAS PLACED ON THE MEDIAL MALLEOLUS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH STABLE PATIENT OUTCOME AND NO SURGICAL DELAY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR A CORTEX SCREW. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7158607 ↗