NA 204.828Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982146328), received between Nov 30, 2017 and Jan 28, 2025 — classified as 13 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024 A GRADE 2 OPEN PILON FRACTURE WITH ASSOCIATED DISTAL FIBULA FRACTURE WAS FIXATED WITH A 2.7MM/3.5MM ANTEROLATERAL DISTAL TIBIA PLATE AND 2.7, MM/ 3.5MM DISTAL FIBULA PLATE. AFTER FIXATION, 6CC OF FIBERGRAFT GPS PUTTY WAS INJECTED INTO THE BONY VOID. THE PATIENT PRESENTED ON (B)(6) 2024 WITH A MECHANICAL FAILURE OF THE CORTICAL SCREWS IN THE SUPERIOR ASPECT OF THE PLATE. NO SCREWS OR THE PLATE WERE BROKEN AND DISTAL BLOCK REMAINED INTACT, SURGEON EXPLAINED THE PATIENT WAS NON-COMPLIANT. THE SCREWS HAD BACKED OUT OF THE PLATE. ON (B)(6) 2025 THE PATIENT WAS REOPERATED ON TO CORRECT MECHANICAL FAILURE. THE SCREWS WERE REPLACED WITH 3.5MM VA LOCKING SCREW. THE VA LCP AND ANTEROLATERAL DISTAL TIBIA PLATE AND LCP DISTAL FIBULA PLATE WERE NOT AFFECTED. UPON OPENING THE INCISION, THE FIBERGRAFT WAS DRAINING FROM THE INCISION AND WAS SENT FOR CULTURE AND CAME BACK NEGATIVE. THE FRACTURE WAS RE-REDUCED AND RE-FIXATED. THERE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21251168 ↗
• MalfunctionSep 17, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ITEM 204.828 IS MISSING FROM THE PACKAGE. THE PLASTIC BAG FOR THE ITEM IS IN THE PACKAGE, BUT THE SCREW WAS NOT IN THE PACKAGE. LOT NUMBER 24200P0 IS LISTED ON THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236056 ↗
• MalfunctionApr 18, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, 3.5MM CORTEX SCREW BROKE WHILE DOING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A GREATER TROCHANTER. THE PATIENT HAD A TOTAL HIP PROSTHESIS IN WHICH THE SCREW WAS BINDING AGAINST. THE BROKEN SHAFT REMAINED IN BONE. THE HEAD OF SCREW WAS REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT WAS LISTED AS OK. THIS REPORT IS FOR ONE 3.5MM CORTEX SCREW SELF-TAPPING 28MM FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133625 ↗
• 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 28MM. THIS IS REPORT 8 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 17755731 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, A PATIENT HAD FULL BODY RASH WHICH BEGAN AFTER AN ANKLE FRACTURE REPAIR WITH ONE (1) 3.5 MM LCP ONE-THIRD TUBULAR PLATE AND EIGHT (8) 3.5 MM CORTEX SCREWS. ALLERGY TESTING HAS CONFIRMED THE PATIENT IS ALLERGIC TO INDIUM (III) CHLORIDE, A COMPOUND FOUND IN SOME METAL ALLOYS WHICH MAYBE OF THE IMPLANTS. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 28MM THIS IS REPORT 3 OF 9 FOR COMPLAINT PC-(B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13793175 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON OR ABOUT (B)(6) 2019 THE PATIENT HAD OPEN REDUCTION ULNAR FRACTURE PROXIMAL END WITH INTERNAL FIXATION OF HIS RIGHT ELBOW. ON OR ABOUT (B)(6) 2020 PATIENT WAS ADMITTED AND HAD AN INCISION, DRAINAGE, AND TREATMENT FOR INFECTION FROM HIS SURGICAL SITE. ON OR ABOUT (B)(6) 2021, THE PATIENT'S INFECTED HARDWARE WAS REMOVED FROM HIS BODY. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 28MM. THIS IS REPORT 4 OF 10 FOR COMPLAINT. PRODUCT COMPLAINT (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 12860337 ↗
• InjuryNov 11, 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 SALES CONSULTANT WAS NOTIFIED OF AN ADD ON CASE. THE PATIENT HAD A COMPLAINT TO BE SEEN AFTER A TIBIA PLATEAU FRACTURE AND REPAIR DUE TO SEVERE PAIN AND OTHER COMPLICATIONS. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) OF 2021 AND THE PATIENT HAD A DRAINING FISTULA AT THE INCISION SITE AS WELL AS IMPROPER REDUCTION OF THE ORIGINAL FRACTURE. THE SURGEON DECIDED TO REMOVE ALL CURRENT HARDWARE AND VERIFY THE PRESENCE OR THE LACK OF PATHOGENS. ALSO THE PATIENTS HEALTH NEEDS TO BE STABLE BEFORE HE CAN PROCEED WITH A REVISION SURGERY, TO PROPERLY REDUCE THE JOINT LINE AND MAKE THE LIMB USEABLE AGAIN FOR THE PATIENT. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 28MM. THIS IS REPORT 16 OF 18 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12797823 ↗
• InjuryNov 11, 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 SALES CONSULTANT WAS NOTIFIED OF AN ADD ON CASE. THE PATIENT HAD A COMPLAINT TO BE SEEN AFTER A TIBIA PLATEAU FRACTURE AND REPAIR DUE TO SEVERE PAIN AND OTHER COMPLICATIONS. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) OF 2021 AND THE PATIENT HAD A DRAINING FISTULA AT THE INCISION SITE AS WELL AS IMPROPER REDUCTION OF THE ORIGINAL FRACTURE. THE SURGEON DECIDED TO REMOVE ALL CURRENT HARDWARE AND VERIFY THE PRESENCE OR THE LACK OF PATHOGENS. ALSO THE PATIENTS HEALTH NEEDS TO BE STABLE BEFORE HE CAN PROCEED WITH A REVISION SURGERY, TO PROPERLY REDUCE THE JOINT LINE AND MAKE THE LIMB USEABLE AGAIN FOR THE PATIENT. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 28MM. THIS IS REPORT 6 OF 18 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12796858 ↗
• InjuryAug 2, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) ELBOW PROCEDURE DUE TO A BROKEN SCREW HEAD. THE BROKEN SCREW HEAD WAS REMOVED EASILY BUT THE SHAFT WAS RETAINED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED: UNK - PLATES: VA-LCP(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNK - SCREWDRIVERS(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 28MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12259139 ↗
• MalfunctionFeb 26, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE SALES REPRESENTATIVE RECEIVED THE PACKING SLIP BUT NO IMPLANTS (TWO (2) 3.5MM CORTEX SCREWS) IN IT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 28MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386599 ↗
• MalfunctionFeb 26, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE SALES REPRESENTATIVE RECEIVED THE PACKING SLIP BUT NO IMPLANTS (TWO (2) 3.5MM CORTEX SCREWS) IN IT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 28MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386564 ↗
• InjuryOct 4, 2019Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2019, A CORTEX SCREW BROKE. THE SCREW APPEARED VERY BENT IN THE FINAL X-RAYS AFTER IMPLANTATION. THE SURGEON DECIDED TO REMOVE IT AND THE SCREW BROKE UPON REMOVAL. THE SURGEON HAD TO MAKE A CORTICAL WINDOW IN THE TIBIA TO GET THE SCREW OUT. ALL THE FRAGMENTS WERE REMOVED. THE BROKEN SCREW WAS REPLACED WITH ANOTHER CORTEX SCREW. THE SURGERY WAS COMPLETED WITH A SURGICAL DELAY OF 20 MINUTES. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Code Available

  MAUDE report 9156431 ↗
• 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 8128436 ↗
• 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 7295072 ↗
• InjuryJan 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT OSTEOSYNTHESIS OF PROXIMAL HUMERUS WITH A 3.5 MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE AND SEVEN (7) SCREWS ON (B)(6) 2017. PROCEDURE WAS COMPLETED SUCCESSFULLY. POST-OPERATIVELY IT WAS NOTED THE PLATE WAS BROKEN. IT WAS ALSO NOTED THAT PATIENT BONE HAS NECROSIS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 WITHOUT ANY ISSUES. IMPLANTS WERE REMOVED. PATIENT WILL RECEIVE UNSPECIFIED ADDITIONAL TREATMENT PRIOR TO IMPLANTING NEW MATERIAL. THIS REPORT IS FOR ONE (1) 3.5 MM CORTEX SCREW SLF-TPNG 28 MM. THIS IS REPORT 7 OF 8 FOR (B)(6).

  Patient problems: Necrosis; No Code Available

  MAUDE report 7209143 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT OSTEOSYNTHESIS OF PROXIMAL HUMERUS WITH A 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE AND SEVEN (7) SCREWS ON (B)(6) 2017. PROCEDURE WAS COMPLETED SUCCESSFULLY. POST-OPERATIVELY IT WAS NOTED THE PLATE WAS BROKEN. IT WAS ALSO NOTED THAT PATIENT BONE HAS NECROSIS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 WITHOUT ANY ISSUES. IMPLANTS WERE REMOVED. PATIENT WILL RECEIVE UNSPECIFIED ADDITIONAL TREATMENT PRIOR TO IMPLANTING NEW MATERIAL. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SLF-TPNG 28MM . THIS IS REPORT 6 OF 8 FOR (B)(4)

  Patient problems: Necrosis; No Code Available

  MAUDE report 7207627 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL SURGERY TO TREAT A LEFT PROXIMAL HUMERUS FRACTURE WAS PERFORMED ON (B)(6) 2017. THE PATIENT WAS IMPLANTED WITH SIXTEEN (16) SYNTHES DEVICES WHICH INCLUDE TWELVE (12) LOCKING SCREWS, THREE (3) CORTEX SCREWS AND ONE (1) PLATE. THE PATIENT RETURNED ON AN UNKNOWN DATE FOR POST-OPERATIVE X-RAYS. THE X-RAYS REVEALED NON-UNION AS THE FRACTURE DID NOT HEAL AS EXPECTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD FALLEN MULTIPLE TIMES POST-OPERATIVELY AND WAS NON-COMPLAINT WITH POST-OPERATIVE CARE. TO ADDRESS THE NON-UNION, SURGEON WILL BE PERFORMING A REVISION FOR HARDWARE REMOVAL ON (B)(6) 2017. IT HAS BEEN DECIDED THAT ALL OF THE 16 IMPLANTED DEVICES WILL BE REMOVED. PATIENT WILL BE REVISED TO A DIFFERENT TREATMENT PLAN AND NO NEW DEVICES WILL BE IMPLANTED; IT IS UNKNOWN IF THAT PROCEDURE OCCURRED AS PLANNED. THERE WAS NO REPORTED PRODUCT PROBLEM AND PER THE X-RAYS, THE DEVICES APPEARED TO BE INTACT. THIS IS REPORT 10 OF 16 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7070986 ↗