NA 78-30020Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613252599647), received between Mar 19, 2019 and Sep 29, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Device Dislodged or Dislocated

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50929173 ↗
• InjurySep 29, 2026Device Dislodged or Dislocated

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50929171 ↗
• MalfunctionApr 8, 2024Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THE PLATE WAS NOT MANUFACTURED CORRECTLY. IT WAS DESIGNED ON THE INCORRECT MODEL WHICH IMPACTED THE DIMENSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060681 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS A REVISION SURGERY PERFORMED TO REMOVE AND REPLACE THE IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 18222454 ↗
• InjuryDec 21, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE PATIENT DEVELOPED AN INFECTION POST OPERATIVE, AND A REVISION SURGERY WAS PERFORMED TO REMOVE THE PRODUCT.

  Patient problems: Unspecified Infection

  MAUDE report 11045851 ↗
• InjuryJan 8, 2020Loss of or Failure to Bond; Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT DURING A SCAN OF THE PATIENT, THE SURGEON LOCATED A NON UNION OF BONE GRAFT. THE SURGEON COMPLETED A RECONSTRUCTION SURGERY TO REMOVE THE PLATE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO OTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 9565467 ↗
• MalfunctionOct 24, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT A CCI WAS REMOVED DUE TO PATIENT HAVING CANCER RETURN. HOWEVER, UPON OPENING THE SITE IT WAS NOTICED THAT THE PLATE HAD BROKE BY A SCREW HOLE, AND IT WAS REMOVED.

  Patient problems: No Code Available

  MAUDE report 9233100 ↗
• InjuryMar 19, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT A PATIENT DEVELOPED A POST-SURGICAL INFECTION AFTER INITIAL IMPLANTATION WITH AN IMPLANT. THE ORIGINAL PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY WITHOUT A DELAY, BUT APPROXIMATELY ONE MONTH LATER DURING A REVISION SURGERY THE BONE WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 8433367 ↗
• InjuryMar 19, 2019Fracture

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT POST-OPERATIVELY A CT SCAN WAS PERFORMED THAT DETERMINED AN IMPLANT PLATE HAD FRACTURED AFTER THE INITIAL SURGERY. A REVISION PROCEDURE IS PLANNED TO REMOVE THE BROKEN PLATE AND IMPLANT A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8432218 ↗