Straumann Membrane Flex 070.008Recalls & reported problems
Collagen Matrix, Inc. · Collagen Membrane 15mm x 20mm · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M4400700080), received between May 28, 2025 and May 28, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
A MEDWATCH FORM, MW5169611 WAS RECEIVED BY COLLAGEN MATRIX, INC. ON MAY 7, 2025. THE MEDWATCH FORM INDICATES THAT A STRAUMANN® MEMBRANE FLEX WAS USED IN A PROCEDURE IN CONJUNCTION WITH OTHER UNKNOWN PRODUCTS. THE INITIAL REPORTER INDICATED APPROXIMATELY 1 TO 1.5 MONTHS POST-IMPLANTATION THE REPORTER EXPERIENCED SIGNIFICANT FACIAL SWELLING, PREDOMINATELY ON THE LEFT SIDE, THE AREA IN WHICH SHE RECEIVED THE IMPLANT. SUBSEQUENT INVESTIGATION REVEALED THAT THE IMPLANT CONTAINED ALUMINUM AND TITANIUM ALLOY. THE REPORTER LATER LEARNED THAT ALUMINUM WAS SUBSEQUENTLY REMOVED FROM THE IMPLANT COMPOSITION, BUT IT WAS PRESENT AT THE TIME OF HER PROCEDURE. DESPITE EXPLANATION AT AN UNKNOWN DATE IN 2025, THE REPORTER STATES THAT THE FACIAL SWELLING PERSISTS TWO YEARS AFTER INITIAL IMPLANTATION. AFTER REVIEW OF THE EVENT, IT HAS BEEN CONCLUDED THAT MULTIPLE PRODUCTS WERE USED DURING THE PROCEDURE INCLUDING A STRAUMANN® MEMBRANE FLEX. STRAUMANN® MEMBRANE FLEX RESORBABLE COLLAGEN MEMBRANE IS A WHITE, NONFRIABLE, RESORBABLE, SINGLE LAYERED, CONFORMABLE COLLAGEN MEMBRANE MATRIX MANUFACTURED FROM PURIFIED PORCINE PERITONEUM. STRAUMANN® MEMBRANE FLEX IS STERILIZED BY GAMMA IRRADIATION AND IS SUPPLIED
Patient problems: Swelling/ Edema
MAUDE report 22100471 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.