OmniPore Customized Surgical Implant OP89021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855421005413), received between Feb 1, 2023 and Feb 1, 2023 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K133046); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE INITIAL REPORT, A MICROTIA PATIENT HAD SURGERY ON (B)(6) 2022 AND NOW HAS A FUNGAL INFECTION OF HIS IMPLANT. THE PATIENT WILL UNDERGO SURGICAL REVISION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16278757 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133046. One submission often covers many models, so check the product and lot details in each record.

• Z-1382-2017 · Jan 25, 2017 · Terminated
  OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right