NA 78-10020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327004021), received between Oct 19, 2018 and Apr 29, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PEEK IMPLANT WAS SENT OUT WITH AN IMPLANT THICKNESS THAT DOES NOT MEET THE THICKNESS SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926746 ↗
• MalfunctionMar 26, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT REQUIRED MODERATE ADJUSTMENT DUE TO CHANGES OF ANATOMY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704468 ↗
• InjuryOct 25, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE ORIGINAL SURGERY TO PLACE THE IMPLANT WAS COMPLETED SUCCESSFULLY. ONE WEEK POST OPERATIVE, THE PATIENT FELT A GAP INFERIORLY ON BOTH THE ANTERIOR AND POSTERIOR ASPECTS OF THE IMPLANT.

  Patient problems: Discomfort

  MAUDE report 18006964 ↗
• MalfunctionAug 12, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT DID NOT FIT CORRECTLY INTO THE DEFECT AREA. ONE OF THE CORNERS OF THE IMPLANT WAS NOT FITTING FLUSH. THE IMPLANT WAS MODIFIED AND IMPLANTED AROUND THE CONTOUR.

  Patient problems: Failure of Implant

  MAUDE report 15220720 ↗
• InjuryJun 15, 2020Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY HOSPITAL PHYSICIAN THAT A PATIENT DEVELOPED A POST-SURGICAL INFECTION AFTER A PROCEDURE WITH AN IMPLANT. THE PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY. THERE ARE NO ADDITIONAL DETAILS AVAILABLE AT THIS TIME.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10155500 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT A PATIENT ACQUIRED AN INFECTION AFTER A CCI SURGERY. THE FLAP WAS REMOVED AND DISCARDED. THE PATIENT'S INFECTION IS BEING TREATED VIA MEDICATIONS, AND A REVISION SURGERY WILL BE PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 7986497 ↗