RCM6 Resorbable Collagen Membrane 5093000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00614950007325), received between Apr 29, 2022 and Apr 29, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  DOCTOR REPORTED AFTER GRAFTING USING RCM6 MEMBRANE DURING A SURGICAL EXTRACTION AND BONE GRAFT, THERE WAS SWELLING OBSERVED IN SURGICAL SITE OF PATIENT. ON (B)(6) 2022, 7 DAYS AFTER THE PROCEDURE, PATIENT REPORTED SORENESS. ON (B)(6) 2022, 16 DAYS AFTER THE PROCEDURE, PATIENT REPORTED HEADACHES AND A LOSS OF TASTE AND SMELL. PATIENT WAS PRESCRIBED ANTIBIOTICS ON (B)(6) 2022 AND SYMPTOMS IMPROVED.

  Patient problems: Headache; Inflammation

  MAUDE report 14253103 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT CLAIMED THAT THERE WAS DRAINAGE AND GINGIVAL INFLAMMATION FOLLOWING A SURGICAL EXTRACTION AND BONE GRAFT PROCEDURE IN WHICH A RCM6 MEMBRANE WAS USED ON (B)(6) 2022. DOCTOR PRESCRIBED ANTIBIOTICS TO TREAT CONDITIONS. NO DELAY IN SURGERY OR INJURY REPORTED. NO REVISION OR MEDICAL INTERVENTION REQUIRED. PATIENT IS DOING BETTER AS OF (B)(6) 2022.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 14253098 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL EXTRACTION WITH BONE GRAFT ON (B)(6)2022. THE PATIENT WAS TAKING Z-PAZK ANTIBIOTICS 2 DAYS PRIOR TO THE SURGICAL PROCEDURE. X-RAYS WERE TAKIEN PRIOR AND AFTER THE SURGICAL EXTRACTION AND BONE GRAFT. THE PATIENT WAS SEEN FOR A FOLLOW UP 7 DAYS LATER AND STILL CLAIMED TO BE SORE. A CT SCAN WAS TAKE 14 DAYS AFTER THE EXTRACTION AND A SINUS INFECTION WAS NOTED. AUGMENTION 500 MG WAS PRESCRIBED ON (B)(6) 2022 AND A Z-PACK CALLED IN ON (B)(6) 2022. THERE WAS A 3 WEEK DELAY IN PROCEDURE NOTED. THE PATIENT WAS REPORTED TO BE "DOING WELL" ON (B)(6) 2022.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation

  MAUDE report 14252941 ↗