NA 204.818Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982146274), received between Dec 12, 2017 and Aug 8, 2025 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT TODAY WHILE DOING A CLAVICLE CASE AT HOSPITAL, DOCTOR STRIPPED 7 TOTAL SCREWS AND COMPLAINED ABOUT THE SCREWDRIVERS/QUALITY OF THE SCREWS. NO BROKEN SCREWS WERE LEFT IN THE PATIENT. THE STRIPPED SCREWS WERE DISCARDED BY THE STAFF. (B)(4) IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750109 ↗
• InjuryNov 19, 2024Corroded; Corroded

  IT WAS REPORTED THAT ON (B)(6) 2024 A REVISION OCCURRED DUE TO PAIN. THE PATIENT'S ORIGINAL SURGERY WAS A RIGHT ULNA ORIF ON (B)(6) 2021. DURING THE REMOVAL IT WAS DISCOVERED MULTIPLE SCREWS WERE RUSTED. SCREWS WERE REMOVED. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 20722543 ↗
• 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 17863721 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON PERFORMED A REMOVAL OF HARDWARE DUE TO PAIN AND IRRITATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.5MM CORTEX SCREW SELF-TAPPING 18MM. THIS IS REPORT 13 OF 14 FOR (B)(4).

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 15628610 ↗
• InjuryFeb 23, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT WAS WALKING, AND HER LEFT FEMUR PLATE BROKE/SNAPPED. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE AN XRAY WAS PERFORMED AND THE PLATE WAS BROKEN. THE BROKEN PLATE WAS REMOVED. CONCOMITANT DEVICE REPORTED: PLATES (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 11366655 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THERE WAS A HARDWARE REMOVAL OF THE ONE THIRD TUBULAR PLATE WITH 7 HOLES AND UNKNOWN SCREWS DUE TO INFECTION. THE TUBULAR PLATE AND UNKNOWN SCREWS WERE IMPLANTED ON AN UNKNOWN DATE. AFTER THE PROCEDURE, THERE WAS A PRESENCE OF INFECTION. PROCEDURE WAS SUCCESSFULLY COMPLETED AND ALL HARDWARE WERE REMOVED. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS 5 OF 8 FOR REPORT (B)(4)..

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9705736 ↗
• MalfunctionDec 6, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE RECEIVED ENVELOPE WAS EMPTY. IT WAS MENTIONED THAT THERE WAS NOTHING IN THE ENVELOPE AND WAS SUPPOSED TO RECEIVE FIVE (5) ITEMS. THERE IS NO PATIENT NOR PROCEDURE INVOLVEMENT. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9428537 ↗
• MalfunctionDec 6, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE RECEIVED ENVELOPE WAS EMPTY. IT WAS MENTIONED THAT THERE WAS NOTHING IN THE ENVELOPE AND WAS SUPPOSED TO RECEIVE FIVE (5) ITEMS. THERE IS NO PATIENT NOR PROCEDURE INVOLVEMENT. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9428415 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) POSTEROLATERAL DISTAL HUMERUS PLATE, ONE (1) 20MM CORTEX SCREW, TWO (2) 18MM CORTEX SCREW, ONE (1) 16MM VA LOCKING SCREW, AND TWO (2) 22MM VA LOCKING SCREWS ON (B)(6) 2018 FOR A RIGHT DISTAL HUMERUS FRACTURE. DURING A POST-OPERATIVE VISIT, SURGEON DETERMINED THERE WAS INADEQUATE FIXATION FOR THE FRACTURE TYPE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE IMPLANTS. IT IS NOT KNOWN WHAT ADDITIONAL HARDWARE WAS IMPLANTED. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW 18MM. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8071629 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MODIFIED EVENT DESCRIPTION UPDATE: 11/16/2018 & 11/19/2018: IT WAS REPORTED PATIENT WAS IMPLANTED WITH A VARIABLE ANGLE LOCKING COMPRESSION (VA LCP) POSTEROLATERAL DISTAL HUMERUS PLATE, THREE (3) CORTEX SCREWS, AND THREE (3) VA LOCKING SCREWS ON (B)(6) 2018 FOR A RIGHT DISTAL HUMERUS FRACTURE. DURING A POST-OPERATIVE VISIT, SURGEON DETERMINED THAT THE WHOLE CONSTRUCT FELL APART AND THERE WAS INADEQUATE FIXATION FOR THE FRACTURE TYPE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE IMPLANTS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 8071571 ↗
• InjuryFeb 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 ON TO 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 SURGERY TO REMOVE THE BROKEN HARDWARE, RESET THE BRO

  Patient problems: Unspecified Infection

  MAUDE report 7295060 ↗
• InjuryFeb 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 ON TO 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) 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) 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 SURGERY TO REMOVE THE BROKEN HARDWARE, RESET THE BROKEN TI

  Patient problems: Unspecified Infection

  MAUDE report 7295050 ↗
• InjuryFeb 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 ON TO 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) 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) 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 SURGERY TO REMOVE THE BROKEN HARDWARE, RESET THE BROKEN TI

  Patient problems: Unspecified Infection

  MAUDE report 7295049 ↗
• InjuryFeb 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OFFICE VISIT (B)(6) 2017: ULCER PRESENT TO RLE (RIGHT LOWER EXTREMITY) AND PATIENT EXPERIENCING MILD PAIN, SWELLING AND ERYTHEMA. PATIENT SUSTAINED A LACERATION. HAS ENLARGED LYMPH NODES BUT NO PAIN ON WEIGHT BEARING. RIGHT INGUINAL LYMPHADENOPATHY PRESENT. RADIOGRAPHICALLY, TIBIA APPEARS TO BE PARTIALLY HEALED. FIBULA OSTEOTOMY IS HEALED. PATIENT REPORTED SHARP, INTERMITTENT, RADIATING PAIN IN HIS RIGHT LOWER LEG. PATIENT¿S VAC (RIGHT MEDIAL LEG) WAS CHANGED ON (B)(6) 2017.

  Patient problems: Unspecified Infection

  MAUDE report 7295042 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HARDWARE REMOVAL SURGERY ON (B)(6), 2017 DUE TO A REFRACTURED ANKLE. THE PATIENT ORIGINALLY UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ANKLE AND WAS IMPLANTED WITH A CANCELLOUS BONE SCREW, 3 CORTEX SCREWS, AND A TUBULAR PLATE ON AN UNKNOWN DATE IN (B)(6) 2017. HOWEVER, SOMETIME LAST WEEK, THE PATIENT TRIPPED ON A CURB AND REFRACTURED HIS LEFT ANKLE. THE RESULTS OF THE HARDWARE REMOVAL SURGERY WERE SUCCESSFUL, THE PATIENT WAS REPORTED TO BE IN EXCELLENT CONDITION. ALL THE ORIGINALLY IMPLANTED HARDWARE WAS REPLACED WITH NEW IMPLANTS. THERE WAS NO REPORTED SURGICAL DELAY. ALL AVAILABLE INFORMATION WAS RECEIVED FROM THE SALES CONSULTANT. THIS IS REPORT 2 OF 5 FOR(B)(4)..

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 7108741 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 7108497 ↗