OmniPore Surgical Implant OP8321Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855421005253), received between Feb 7, 2019 and Feb 7, 2019 — classified as 1 injury.

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

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

• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  EMAIL NOTIFICATION WAS RECEIVED FROM OUR DISTRIBUTOR (B)(4) ON FEB. 21, 2018 INDICATING THAT A PHYSICIAN REPORTED PATIENT DEVELOPED A POST-SURGICAL INFECTION AFTER THE IMPLANTATION OF AN OMNIPORE TWO-PIECE CHIN (OP8321). DEVICE WAS IMPLANTED ON (B)(6) 2017. IT WAS REPORTED THAT 1 MONTH AFTER SURGERY THE PATIENT BEGAN TO HAVE AN INFLAMMATORY REACTION, SECRETION, EDEMA AND SWELLING. THE PHYSICIAN DRAINED THE SITE AND PRESCRIBED ANTIBIOTIC. THE PATIENT HAD AN IMPROVEMENT FOR 15 DAYS, THEN CAME BACK PRESENTING THE SAME INFLAMMATORY CONDITION. THE PHYSICIAN PERFORMED A SURGERY REMOVING AND CLEANING THE IMPLANTED DEVICE, TREATING PATIENT WITH ANTIBIOTIC, AND RE-IMPLANTED THE ORIGINAL DEVICE. AFTER 2 WEEKS, PATIENT RETURNED WITH ALL THE SAME REACTIONS AND ON (B)(6) 2018 THE IMPLANTED DEVICE WAS REMOVED. TODAY THE PATIENT IS WELL.

  Patient problems: Edema; Inflammation; Unspecified Infection

  MAUDE report 8318300 ↗

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