NA 214.828Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982154637), received between Jan 7, 2021 and Jul 3, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED A REVISION SURGERY OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2023. THE TECHNICAL ASSISTANT PERFORMED THE PRE-OPERATIVE PLAN WITH THE SURGEON, WHICH WAS NOTED AS "THE PLAN IS TO REMOVE THE MEDIAL PLATE. THE LATERAL PLATE WILL BE LEFT. ONLY THE DISTAL SCREWS ARE TO BE RELEASED. THE OSTEOTOMY WILL BE PERFORMED, AND THE INSERT WILL BE PLACED TO CORRECT THE PSEUDOARTHROSIS". DURING THE PROCEDURE THE MEDIAL PLATE WAS REMOVED AND THEN THE DISTAL SCREWS OF THE LATERAL PLATE WERE REMOVED, BUT THE PLATE WAS NOT REMOVED. OSTEOTOMY WAS PERFORMED AND THE INSERT WAS PLACED, THEN PROCEEDED TO FIX THE PLATE USING NEW SCREWS FROM J&J. IT SHOULD BE NOTED THAT 2 INTERFRAGMENTARY COMPRESSION SCREWS WERE ALSO PLACED. THE PROCEDURE ENDED WITHOUT ANY NOVELTY AND WITH TOTAL NORMALITY. THE PLATE IMPLANTED IN THE PATIENT WAS FROM ANOTHER BRAND, AND THE SCREWS TO FIX THIS PLATE ARE FROM J&J. ORIGINAL IMPLANT DATE WAS NOT NOTED. THIS IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 28MM FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17246747 ↗
• MalfunctionJul 8, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED ON UNKNOWN DATE THAT WHILE RESTOCKING THE CONSULTANT NOTICED THAT THE SET OF PACKAGE FOR THE SCREW WAS EMPTY, NO DAMAGE TO THE PACKAGE. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 28MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14954816 ↗
• InjuryOct 19, 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 REVISION FIXATION OF HARDWARE. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THE IMPLANTS WERE ORIGINALLY PLACED IN THE PATIENT ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 28MM. THIS IS REPORT 4 OF 7 FOR (B)(4).

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

  MAUDE report 12657487 ↗
• InjuryOct 19, 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 REVISION FIXATION OF HARDWARE. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THE IMPLANTS WERE ORIGINALLY PLACED IN THE PATIENT ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 28MM. THIS IS REPORT 1 OF 7 FOR (B)(4).

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

  MAUDE report 12657246 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DUE TO INFECTION THE PATIENT UNDERWENT FOR A REVISION SURGERY TO REMOVE DEFECTIVE FRACTURED 4.5 MM PROXIMAL TIBIAL PLATE AND OTHER ASSOCIATED SCREWS. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES (7) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 28MM. THIS REPORT IS 2 OF 7 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

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

  MAUDE report 12001913 ↗
• 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. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 28MM, THIS REPORT IS 7 OF 10 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11132543 ↗