OSSIX® PLUS OXP2530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290015477727), received between Sep 20, 2016 and Mar 7, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  66-YEAR-OLD FEMALE WITH PAST CANCER HX BUT IN REMISSION. NO MEDS CONTRA INDICATING IMPLANT PLACEMENT. HAD A SINGLE ANTHOGYR DELAYED IMPLANT PLACED IN THE LL6 SITE WITH NO THREADS EXPOSED, BUT WITH NEED FOR HORIZONTAL BONE AUGMENTATION. THIS WAS UNDERTAKEN WITH PUROS ALLOGRAFT PARTICLES AND THE 25X 30 MM OSSIX PLUS MEMBRANE STABILIZED WITH PERIOSTEAL SLING SUTURES. THE IMPLANT AND GRAFT WERE BURIED AND THE CLOSURE ACHIEVED BY PRIMARY STABILITY. THE 2-WEEK STITCH REMOVAL WAS UNEVENTFUL AND THE PATIENT HAD NO PAIN AT ANY STAGES. AT THE 3-MONTH EXPOSURE APPOINTMENT, THE SITE HAD A SINUS TRACT WITH PUS DISCHARGE AND THE BONE GRAFT AND IMPLANT WERE COMPLETELY COMPROMISED. THERE WAS SOFT TISSUE INSTEAD OF NEW BONE AND WHEN THIS WAS REMOVED , BUCCAL AND VERTICAL BONE LOSS WAS EVIDENT; DOCTOR EXPLANTED THE IMPLANT.

  Patient problems: Impaired Healing

  MAUDE report 18862975 ↗
• InjurySep 20, 2016Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DENTIST USED THE MEMBRANE OVER BONE GRAFT AND AT THE TIME OF IMPLANT PLACEMENT, TISSUE DIED BACK OVER THE MEMBRANE. BONE WAS EXPOSED AND THE DENTAL IMPLANT FAILED. THE PATIENT HAD POOR HEALING AND DENTIST IS CONCERNED ABOUT RESIDUAL ETO IN THE MEMBRANE. UPDATE ON 8/26/2016: THE IMPLANT WHICH UNDERWENT CONCOMITANT GUIDED BONE REGENERATION HAD AN INFECTION AND IMPLANT FAILURE. THE MEMBRANE BECAME EXPOSED AND DISSOLVED. PATIENT WAS PLACED ON ZITHROMAX AND ALL ADVERSE EVENTS HAVE RESOLVED. THIS AE IS SLIGHTLY POSSIBLY RELATED TO THE OSSIX PLUS AND MORE LIKELY NOT RELATED TO THE MEMBRANE OR THE ETO. UPDATE ON 9/1/2016: THE DOCTOR PLACED 7 IMPLANTS IN A PATIENT AND ONE IMPLANT WHICH UNDERWENT CONCOMITANT GUIDED BONE REGENERATION HAD AN INFECTION AND IMPLANT FAILURE. THE INITIAL INFECTION STARTED AROUND THE SOFT TISSUE, PATIENT WAS PLACED ON ZITHROMAX (PENICILLIN ALLERGY), THEN SWITCHED TO METRONIDAZLE. IMPLANT FAILED IN 2 WEEKS WHEN BECAME LOOSE, THEN SECOND IMPLANT 2 WEEKS LATER. THE DOCTOR FEELS THE IMPLANTS WERE PLACED ACCORDING TO ACCEPTABLE SURGICAL PROTOCOL. THE AE RESOLVED AND THE PATIENT IS FINE. UPDATE ON 9/14/2016: THE DENTIST CLARIFIED THAT THERE WAS N

  Patient problems: Impaired Healing; Purulent Discharge; Unspecified Infection

  MAUDE report 5964939 ↗