OmniPore Surgical Implant OP8330Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00855421005284), received between Dec 3, 2019 and Sep 1, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K123908); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2021Fracture; Fracture

  ACCORDING TO THE INITIAL REPORT, THE SURGEON STATED THAT A PATIENT EXPERIENCED AN IMPLANT FRACTURE AND NEEDED A REPLACEMENT FOR SURGICAL INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 12408172 ↗
• InjurySep 1, 2021Fracture; Fracture

  ACCORDING TO THE INITIAL REPORT, THE SURGEON STATED THAT A PATIENT EXPERIENCED AN IMPLANT FRACTURE AND NEEDED A REPLACEMENT FOR SURGERY INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 12407603 ↗
• InjuryDec 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE INITIAL REPORT, A KOREAN PATIENT WITH AN INFECTION THAT NEEDS HIS IMPLANT REPLACED. THERE WAS AN EXPOSURE THAT LED TO IMPLANT CONTAMINATION. NOT A REAL INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9401291 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123908. One submission often covers many models, so check the product and lot details in each record.

• Z-1223-2019 · Jan 30, 2019 · Terminated
  OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applicatio
• Z-1224-2019 · Jan 30, 2019 · Terminated
  OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applicatio
• Z-1382-2017 · Jan 25, 2017 · Terminated
  OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right