DuraMatrix Onlay CDSLM45Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813954020273), received between Oct 5, 2017 and Jul 22, 2025 — classified as 3 injuries.

1 FDA recall record name this device's identifier.

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 16, 2026.

Recalls naming this device

1. Dec 13, 2021Terminated

   Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

   Z-0668-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION, WITH LIMITED DETAILS PROVIDED. FURTHER INFORMATION REGARDING THE PATIENT OR EVENT IS UNLIKELY TO BECOME AVAILABLE. THE PRODUCT INVOLVED IS DURAMATRIX-ONLAY®. A PATIENT EXPERIENCED AN ADVERSE EVENT (AE) CHARACTERIZED AS WOUND DEHISCENCE WITH PURULENT DISCHARGE. THE INITIAL SURGERY WAS (B)(6) 2025 AND THE LOCATION OF THE IMPLANT WAS THE ANTERIOR FOSSA. NO SUTURES, SEALANTS OR OTHER DURAL CLOSURE PRODUCTS WERE USED DURING THE PROCEDURE. NO CSF LEAK WAS OBSERVED POST-PLACEMENT. A DRAINAGE SHUNT WAS USED. A ROUTINE FOLLOW UP VISIT ON (B)(6) 2025 NOTED NO ADVERSE EVENTS. HOWEVER, A SUBSEQUENT FOLLOW-UP VISIT ON (B)(6) 2025 INDICATED WOUND DEHISCENCE ON THE "SCALP, WOUND". THE PATIENT WAS INITIALLY PRESCRIBED CEPHALEXIN WHICH WAS SWITCHED TO DOXYCYCLINE DUE TO SENSITIVITIES. CLINICAL DATA COLLECTION INDICATED THAT THE ADVERSE EVENT WAS UNRELATED TO THE INTERVENTION. NO SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION SURROUNDING PATIENT STATUS OR PATIENT OUTCOME WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22568587 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY FURTHER INFORMATION SURROUNDING THE PATIENT OR THE EVENT WILL BE PROVIDED. DURAMATRX-ONLAY COLLAGEN DURA MEMBRANE USED ON A PATIENT ON (B)((6) 2025 IN THE ANTERIOR FOSSA. PATIENT WAS PART OF CLINICAL STUDY FOR MENINGIOMA WHO GRADE 1. AT TIME OF INITIAL SURGERY, 3-0 AND 4-0 SYNTHETIC, NON-ABSORBABLE SUTURES WERE USED (NOT COLLAGEN MATRIX, INC. PRODUCTS). NO OTHER DURAL PRODUCTS WERE UTILIZED. A DRAINAGE SHUNT WAS ALSO USED (NOT A COLLAGEN MATRIX, INC. PRODUCT). THERE WERE NO COMPLICATIONS NOTED DURING THE INITIAL SURGERY. THERE WAS NO CSF LEAKAGE AFTER INITIAL PLACEMENT. THE CLINICIAN CLASSIFIED THE HANDLING PROPERTIES OF THE DURAMATRIX-ONLAY PRODUCT AS "GOOD" AND ALSO CLASSIFIED THE ADAPTABILITY OF THE PRODUCT TO ANATOMIC STRUCTURE AS "GOOD." AN ADVERSE EVENT WAS REPORTED ON 5/31/2025, IN WHICH AN INTRACRANIAL ABSCESS POST CRANIECTOMY IN THE BONE FLAP WAS NOTED. CLINICIAN CLASSIFIED THIS AS A SERIOUS, BUT UNEXPECTED, ADVERSE EVENT. HOSPITALIZATION WAS REQUIRED. INTERVENTION REQUIRED AS ADDITIONAL SURGERY WAS PERFORMED TO RE-DO THE CRANIECTOMY AND EVACUATION OF ABSCESS AND WASHOUT.

  Patient problems: Abscess

  MAUDE report 22560140 ↗
• InjuryOct 5, 2017Appropriate Device Problem Term/Code Not Available

  IT WAS INITIALLY REPORTED THAT THE DURAMATRIX ONLAY (CDSLM45) PRODUCT IN COMBINATION WITH DURAMATRIX SUTURABLE (DMS45; EMDR REPORT 2249852-2017-00017) WAS USED AS PART OF A POST AREA FOSSA CRANIOTOMY PROCEDURE WHICH RESULTED IN FOLLOW-UP SURGERY TO FIX A CEREBROSPINAL FLUID LEAK. BASED ON ADDITIONAL INFORMATION RECEIVED ON 10/11/2018, IT HAS BEEN DETERMINED THAT THE DURAMATRIX ONLAY (CDSML45) PRODUCT WAS NOT USED OR ASSOCIATED WITH THE INITIALLY REPORTED INCIDENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6915042 ↗