OmniPore Surgical Implant OP8322Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855421005499), received between Feb 7, 2019 and Feb 22, 2019 — classified as 2 injuries.

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

• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PHONE CALL MESSAGE WAS RECEIVED BY (B)(6) (VP MARKETING) ON (B)(6) 2019 FROM SURGEON REPORTING THAT A PATIENT HAD DEVELOPED A POST-OPERATIVE INFECTION AFTER THE IMPLANTATION OF THE TWO-PIECE CHIN. NO OTHER INFORMATION WAS RECEIVED AT THE TIME OF THIS INITIAL CONTACT. PRODUCT INFORMATION WAS MADE AVAILABLE BY THE REVIEW OF DISTRIBUTION RECORDS.

  Patient problems: Patient Problem/Medical Problem; Post Operative Wound Infection

  MAUDE report 8362264 ↗
• 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 NOV. 30, 2018 INDICATING THAT A PATIENT DEVELOPED A POST-SURGICAL INFECTION POST THE IMPLANT OF AN OMNIPORE TWO-PIECE CHIN (OP8322). THE FOLLOWING INFORMATION WAS RECEIVED: THE SURGEON REPORTED THAT THEY FOLLOWED THE PROTOCOL BUT EVEN SO COULD NOT MOLD THE PRODUCT WHICH WAS EXTREMELY HARD EVEN WARMED. AFTER IMPLANTATION, THE PROTHESIS GOT A SPACE BETWEEN IT AND THE BONE. AFTER SURGERY, IN THE SPACE BETWEEN THE PROTHESIS AND THE BONE, THE PATIENT BEGAN TO HAVE AN INFLAMMATORY REACTION, EDEMA AND PAIN. SO THEN, THE SURGEON REMOVED THE IMPLANT AND DISCARDED IT. DATE OF SURGERY: (B)(6) 2018. PATIENT´S NAME: (B)(6). SURGEON´S NAME: (B)(6). PRODUCT CODE: OP8322. LOT: 9003070616.

  Patient problems: Edema; Inflammation; Patient Problem/Medical Problem

  MAUDE report 8318307 ↗

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