NA 207.756Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982148582), received between Feb 5, 2018 and Sep 5, 2025 — classified as 4 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS REQUESTING INFORMATION REGARDING ANY POTENTIAL RECALLS AND MATERIAL MAKEUP OF HER PLATE AND SCREWS DUE TO SYMPTOMS SHE IS EXPERIENCING SINCE THE IMPLANTATION IN (B)(6) 2016 FOR A BROKEN ANKLE AND TIBIA. SYMPTOMS BEGAN 9 MONTHS AFTERWARD AND INCLUDE HYPERSENSITIVITY, AN IMMUNE RESPONSE THAT HAS "MESSED UP HER SYSTEM," HIGH TITER, DISCOID LUPUS, SKIN ISSUES, BODY ACHES, FATIGUE, FEVERS, JOINT PAIN, STIFFNESS, REDNESS, AND EXTREME FATIGUE. PATIENT'S SURGEON WOULD LIKE TO PERFORM AN MRI AND POTENTIALLY REMOVE THE DEVICE.

  Patient problems: Fatigue; Fever; Hypersensitivity/Allergic reaction; Muscular Rigidity; Pain; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 22986009 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OCTOBER 18 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) 4.0MM CANNULATED SCREW-LONG THREAD 56MM. THIS IS REPORT 9 OF 18 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12797477 ↗
• InjuryFeb 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2016, PATIENT UNDERWENT SURGERY TO TREAT A LEFT ANKLE FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 2.7 MM/3.5 MM LCP LATERAL DISTAL PLATE AND TEN (10) SCREWS. IT WAS UNKNOWN TO THE SURGEON IF THE PATIENT WAS ALLERGIC TO METAL AT THE TIME OF THE INITIAL SURGERY. SUBSEQUENTLY THE PATIENT FELT SOME SOFT TISSUE IRRITATION AND THIS WAS DISCOVERED TO BE A REACTION TO METAL ALLERGY. THE SURGEON THEN DECIDED TO REMOVE ALL IMPLANTED DEVICES AND THE CONSTRUCT WITH ALL DEVICES INTACT WAS REMOVED ON (B)(6) 2018. INTRA-OPERATIVE X-RAYS TAKEN SUGGESTED THAT THE FRACTURE HAD COMPLETELY HEALED. THE REMOVAL OF PLATE AND SCREWS CONSTRUCT WAS COMPLETED SUCCESSFULLY AND WITHOUT ANY COMPLICATIONS. NO ADDITIONAL INTERVENTIONS WERE REQUIRED AND THERE WAS NO SURGICAL DELAY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 4.0 MM CANNULATED SCREW-LONG THREAD 56 MM. THIS IS REPORT 2 OF 11 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7242221 ↗
• InjuryFeb 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2016, PATIENT UNDERWENT SURGERY TO TREAT A LEFT ANKLE FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 2.7MM/3.5MM LCP LATERAL DISTAL PLATE AND TEN (10) SCREWS. IT WAS UNKNOWN TO THE SURGEON IF THE PATIENT WAS ALLERGIC TO METAL AT THE TIME OF THE INITIAL SURGERY. SUBSEQUENTLY THE PATIENT FELT SOME SOFT TISSUE IRRITATION AND THIS WAS DISCOVERED TO BE A REACTION TO METAL ALLERGY. THE SURGEON THEN DECIDED TO REMOVE ALL IMPLANTED DEVICES AND THE CONSTRUCT WITH ALL DEVICES INTACT WAS REMOVED ON (B)(6) 2018. INTRA-OPERATIVE X-RAYS TAKEN SUGGESTED THAT THE FRACTURE HAD COMPLETELY HEALED. THE REMOVAL OF PLATE AND SCREWS CONSTRUCT WAS COMPLETED SUCCESSFULLY AND WITHOUT ANY COMPLICATIONS. NO ADDITIONAL INTERVENTIONS WERE REQUIRED AND THERE WAS NO SURGICAL DELAY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW-LONG THREAD 56MM. THIS IS REPORT 9 OF 11 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7242124 ↗