NA 219.98Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982156280), received between Oct 8, 2018 and Sep 12, 2025 — classified as 12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HARDWARE REMOVAL RFNA AND REVISED DUE TO NON-UNION. THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23042668 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HARDWARE REMOVAL OF RFNA AND WAS REVISED DUE TO NON-UNION.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23038364 ↗
• InjuryNov 11, 2022Adverse 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 OPEN REDUCTION INTERNAL FIXATION DUE TO RIGHT MEDIAL MALLEOLUS FRACTURE. IN RADIOLOGY ON (B)(6) 2021, STABLE FIXATION RIGHT SYNDESMOSIS AND RIGHT FIBULA. MEDIAL MALLEOLAR FRAGMENT WITH DISPLACEMENT. THIS REPORT IS FOR ONE (1) WASHER 7.0MM. THIS IS REPORT 8 OF 10 FOR COMPLAINT: (B)(6).

  Patient problems: Bone Fracture(s); Physical Asymmetry

  MAUDE report 15781195 ↗
• InjuryMay 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REMOVAL OF ANKLE PLATES AND HARDWARE OCCURRED. THE SHAFT REMAINED IN THE PATIENT AND THE BROKEN HEAD WAS REMOVED FROM THE PATIENT. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR (1) 2.7 CALC RECONSTRUCTION PL 8 HOLES/64. THIS IS REPORT 6 OF 11 FOR COMPLAINT (B)(4).

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

  MAUDE report 14467176 ↗
• 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) WASHER 7.0MM. THIS IS REPORT 10 OF 18 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12797562 ↗
• 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) WASHER 7.0MM. THIS IS REPORT 18 OF 18 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12797432 ↗
• 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) WASHER 7.0MM. THIS IS REPORT 10 OF 11 FOR (B)(4).

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

  MAUDE report 12489482 ↗
• 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 (1) WASHER 7.0MM. THIS IS REPORT 5 OF 11 FOR (B)(4).

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

  MAUDE report 12489194 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF AN ANTERIORMEDIAL DISTAL TIBIA PLATE AND SCREWS DUE TO INFECTION AND NON-UNION. THE SURGEON REMOVED AN ANTERIORMEDIAL DISTAL TIBIA PLATE AND SCREWS ALONG WITH SOME CANNULATED SCREWS FROM THE DISTAL TIBIA. THE REASON FOR REMOVAL IS AN INFECTED NON UNION. THERE WERE NO ALLEGATIONS AGAINST THE DEVICES. THE SURGEON DECIDED NOT TO TAKE ALL THE HARDWARE OUT THAT DAY AND BRING THE PATIENT BACK AT A LATER DATE TO REMOVE THE REST OF IT. A DISTAL TIBIA PLATE AND SCREW REMAINED IN THE PATIENT. IT WAS ULTIMATELY DECIDED NOT TO REMOVE ANY MORE OF THE HARDWARE BECAUSE THE INFECTION WAS SUBSIDING. THE SURGEON PUT A CIRCULAR FIXATOR ON THE ANKLE FOR DEFINITIVE FIXATION. THIS PRODUCT WAS IMPLANTED IN (B)(6) 2020. THIS REPORT IS FOR (1) WASHER 7.0MM. THIS IS REPORT 12 OF 17 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 12453627 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF AN ANTERIORMEDIAL DISTAL TIBIA PLATE AND SCREWS DUE TO INFECTION AND NON-UNION. THE SURGEON REMOVED AN ANTERIORMEDIAL DISTAL TIBIA PLATE AND SCREWS ALONG WITH SOME CANNULATED SCREWS FROM THE DISTAL TIBIA. THE REASON FOR REMOVAL IS AN INFECTED NON UNION. THERE WERE NO ALLEGATIONS AGAINST THE DEVICES. THE SURGEON DECIDED NOT TO TAKE ALL THE HARDWARE OUT THAT DAY AND BRING THE PATIENT BACK AT A LATER DATE TO REMOVE THE REST OF IT. A DISTAL TIBIA PLATE AND SCREW REMAINED IN THE PATIENT. IT WAS ULTIMATELY DECIDED NOT TO REMOVE ANY MORE OF THE HARDWARE BECAUSE THE INFECTION WAS SUBSIDING. THE SURGEON PUT A CIRCULAR FIXATOR ON THE ANKLE FOR DEFINITIVE FIXATION. THIS PRODUCT WAS IMPLANTED IN (B)(6) 2020. THIS REPORT IS FOR ONE (1) WASHER 7.0MM. THIS IS REPORT 6 OF 17 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 12453595 ↗
• InjuryAug 26, 2020Adverse 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 REVISION SURGERY DUE TO A MAL REDUCTION OF FRAGMENTS. THE SURGEON HAD REMOVED 3.5 AND 4.0 CANNULATED SCREWS FROM A DISTAL HUMERUS FRACTURE THAT WAS MAL REDUCED. THE SURGEON DID NOT INDICATE AN ALLEGATION AGAINST THE DEVICES, RATHER WITH THE SURGICAL TECHNIQUE THAT LED TO MAL REDUCTION AND REVISION. THE ORIGINAL SURGERY WAS AROUND (B)(6) 2020. THE UNKNOWN 2.4 HEADLESS SCREWS WERE THEN USED TO FIXATE THE REDUCED FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) WASHER 7.0MM. THIS IS REPORT 3 OF 4 (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10455524 ↗
• InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT AN ANKLE PROCEDURE IN (B)(6) 2018 TO IMPLANT TWO (2) LOCKING COMPRESSION PLATE (LCP) ONE THIRD TUBULAR PLATES, ONE (1) 2.7/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) ANTEROLATERAL DISTAL TIBIA PLATE, ONE (1) 2.7/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) MEDIAL DISTAL TIBIA PLATE, THIRTEEN (13) 3.5MM CORTEX SCREWS, TWELVE (12) 2.7MM VA LOCKING SCREWS, ONE (1) 7.0MM WASHER, ONE (1) 4.0MM CANNULATED SCREW, AND TWO (2) 4.0MM CANCELLOUS SCREWS. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED DUE TO INFECTION, INFLAMMATION, AND DELAYED HEALING. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS REPORTED AS OKAY. PATIENT IS REPORTED TO BE INCARCERATED AND NON-COMPLIANT. THIS REPORT IS FOR A 7.0MM WASHER THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7944655 ↗