NA 204.814Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10886982146250), received between Feb 5, 2018 and Jun 22, 2023 — classified as 51 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2023Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5117887, A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS DISCHARGED HOME. THIS REPORT INVOLVES ONE 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 17180784 ↗
• MalfunctionApr 28, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A PRODUCT MISSING FROM ITS PACKAGING UPON RECEIPT. THEY WANTED TO REPORT THIS COMPLAINT AND WOULD NEED A RESHIPMENT OF THIS PRODUCT, THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16837628 ↗
• 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 14MM. THIS IS REPORT 11 OF 14 FOR (B)(4).

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 15628530 ↗
• InjuryJul 20, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT REVISED THE PLATE DUE TO SCREWS PULLING OUT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15070879 ↗
• InjuryJul 20, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT REVISED THE PLATE DUE TO SCREWS PULLING OUT .IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1)3.5MM CORTEX SCREW SELF-TAPPING 14MM THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15070779 ↗
• InjuryJul 20, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT REVISED THE PLATE DUE TO SCREWS PULLING OUT .IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15070667 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 12 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, THE PATIENT UNDERWENT A DEVICE REMOVAL ON (B)(6) 2022 IN THE RIGHT ANKLE DUE TO PAIN. IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED SUCCESSFULLY AND WITHOUT COMPLICATION. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

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

  MAUDE report 14159436 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 12 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, THE PATIENT UNDERWENT A DEVICE REMOVAL ON (B)(6) 2022 IN THE RIGHT ANKLE DUE TO PAIN. IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED SUCCESSFULLY AND WITHOUT COMPLICATION. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

  Patient problems: Pain

  MAUDE report 14147730 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 12 FOR PC-(B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, THE PATIENT UNDERWENT A DEVICE REMOVAL ON (B)(6) 2022 IN THE RIGHT ANKLE DUE TO PAIN. IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED SUCCESSFULLY AND WITHOUT COMPLICATION. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

  Patient problems: Pain

  MAUDE report 14147721 ↗
• InjuryFeb 24, 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 PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 7 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13590905 ↗
• InjuryFeb 24, 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 PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. (2) 6 HOLE 3.5 LCP PLATES, (8) 14MM 3.5 CORTEX SCREWS, AND (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 3 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13590896 ↗
• InjuryFeb 24, 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 PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 8 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13590886 ↗
• InjuryFeb 24, 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 PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 5 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13590883 ↗
• InjuryFeb 24, 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 PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 6 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13590882 ↗
• InjuryFeb 24, 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 PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 2 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13590875 ↗
• InjuryFeb 24, 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 PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 4 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13590873 ↗
• InjuryFeb 24, 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 PATIENT UNDERWENT A REVISION OF A BOTH BONE FOREARM FRACTURE. TWO (2) 6 HOLE 3.5 LCP PLATES, EIGHT (8) 14MM 3.5 CORTEX SCREWS, AND FOUR (4) 12MM 3.5 CORTEX SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND NEW IMPLANTS WERE PLACED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 1 OF 14 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13590872 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF ONE (1) LOCKING COMPRESSION PLATE (LCP) WITH FIVE (5) CORTEX SCREWS AND ONE (1) LOCKING SCREW DUE TO NONUNION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12779689 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF ONE (1) LOCKING COMPRESSION PLATE (LCP) WITH FIVE (5) CORTEX SCREWS AND ONE (1) LOCKING SCREW DUE TO NONUNION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12779679 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF ONE (1) LOCKING COMPRESSION PLATE (LCP) WITH FIVE (5) CORTEX SCREWS AND ONE (1) LOCKING SCREW DUE TO NONUNION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12779672 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF ONE (1) LOCKING COMPRESSION PLATE (LCP) WITH FIVE (5) CORTEX SCREWS AND ONE (1) LOCKING SCREW DUE TO NONUNION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12779547 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE HARDWARE IN QUESTION WAS REMOVED DUE TO INFECTION. IT IS UNKNOWN WHEN THE HARDWARE WAS ORIGINALLY IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 3 OF 11 FOR (B)(4).

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

  MAUDE report 12489030 ↗
• InjuryMay 24, 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 FOR THE FIBULA PLATE AND SCREWS AND 2 ASSOCIATED LAG SCREWS. THE SURGEON PERFORMED I&D AND NOTED THAT THE BONE IS MOSTLY HEALED AND APPEARED TO HAVE NO SIGN OF INFECTION. INITIALLY THE PATIENT HAD SURGERY TO REPAIR A FIBULA FRACTURE 4 OR 5 MONTHS AGO. AFTER 3 MONTHS POST OP THERE WAS A SIGN OF INFECTION AND TRIED TO TREAT WITH ANTIBIOTICS WITHOUT SUCCESS. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS REPORT IS 2 OF 14 (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11873569 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN SURGERY, LOCKING COMPRESSION PLATE, CORTEX SCREWS, AND LOCKING SCREWS WERE TAKEN OUT DUE TO PATIENT PAIN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.7MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 202.816, LOT UNKNOWN, QUANTITY 1). 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1). 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM (PART NUMBER 02.112.048, LOT UNKNOWN, QUANTITY 1). 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM (PART NUMBER 212.104, LOT UNKNOWN, QUANTITY 1). 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1). 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1). 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11163481 ↗
• 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. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 14MM. THIS IS REPORT 7 OF 8 FOR (B)(4). ADDITIONAL DEVICE ARE CAPTURED UNDER RELATED (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11135859 ↗