OsseoGuard OG1520Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813954020327), received between May 27, 2020 and Dec 12, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Disintegration” (1 report).

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.

• InjuryDec 12, 2025Material Disintegration; Material Disintegration

  THIS ADVERSE EVENT OCCURRED OUTSIDE OF THE U.S. HOWEVER, AS THERE IS A SIMILARLY MARKETED DEVICE IN THE U.S., AN MDR IS BEING FILED. PATIENT HAD AN UNSPECIFIED PROCEDURE PERFORMED ON (B)(6) 2024. OSSEOGUARD RESORBABLE MEMBRANE WAS USED ON A PATIENT IN TOOTH SITES 46 AND 47 IN CONJUNCTION WITH PUROS 67210 + 67212 (PUROS PRODUCT IS NOT MANUFACTURED BY COLLAGEN MATRIX, INC.). CUSTOMER STATES THE MEMBRANE "DISSOLVED IN 3 DAYS." ON (B)(6) 2024, IT WAS REPORTED THE PATIENT HAD AN ALLERGIC REACTION WITH "STRONG SWELLING, ABSCESS, INFLAMMATION, REDNESS AND COLLECTION OF PUS" AND THE WOUND WOULD NOT HEAL. THE PATIENT REPORTED "GREAT PAIN." THE CUSTOMER STATED THE PRODUCT WAS REMOVED ON (B)(6) 2024. IT IS UNCLEAR WHICH PRODUCT WAS REMOVED, BUT CUSTOMER BELIEVES IT WAS THE PUROS PRODUCT REMOVED. CUSTOMER STATED THE PATIENT IS "OK AFTER REMOVAL OF THE MATERIAL." THERE IS NO TREATMENT PLAN FINALIZED YET, AS THE PATIENT AND CLINICIAN ARE "MAKING DECISIONS, POSSIBLY TRANSFER TO ORAL AND MAXILLOFACIAL SURGERY." ADDITIONAL CLARIFICATION SURROUNDING THE DATES AND EVENTS AND PATIENT STATUS/PATIENT OUTCOME WAS REQUESTED BUT NOT YET PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23794863 ↗
• InjuryMay 27, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CLINICIAN CLAIMED THAT THE MEMBRANE BROKE IN HALF WHEN THEY TRIED BENDING IT FOR PLACEMENT. THE CLINICIAN USED ANOTHER MEMBRANE TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT REPORTED AND THERE WAS A HALF HOUR DELAY IN PROCEDURE NOTED..

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10093594 ↗