BioMend 0103ZRecalls & reported problems
Collagen Matrix, Inc. · Absorbable Collagen Membrane · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813954020471), received between Aug 23, 2018 and Dec 23, 2019 — classified as 1 injury, 3 malfunctions.
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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
- Insufficient Device Problem Information1
Patient problems
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
THE CLINICIAN CLAIMED THAT THERE WAS A FAILURE WITH THE PRODUCT. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR ANY ADVERSE EVENTS ASSOCIATED WITH THIS INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9512431 ↗MalfunctionAug 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE DOCTOR REPORTED DURING ROUTINE FOLLOW-UP VISIT, ONE WEEK AFTER THE INITIAL IMPLANTATION OF THE MEMBRANE, THE MEMBRANE WAS GONE. TYPICAL PRODUCT RESORPTION AS INDICATED IN THE INSTRUCTIONS FOR USE IS APPROXIMATELY 8 WEEKS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7810305 ↗MalfunctionAug 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE DOCTOR REPORTED DURING ROUTINE FOLLOW-UP VISIT, ONE WEEK AFTER THE INITIAL IMPLANTATION OF THE MEMBRANE, THE MEMBRANE WAS GONE. TYPICAL PRODUCT RESORPTION AS INDICATED IN THE INSTRUCTIONS FOR USE IS APPROXIMATELY 8 WEEKS. THE CLINICIAN PERFORMED A FOLLOW-UP SURGICAL INTERVENTION TO RE-GRAFT THE SITE WITH ANOTHER MEMBRANE
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7810302 ↗MalfunctionAug 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE DOCTOR REPORTED DURING ROUTINE FOLLOW-UP VISIT, ONE WEEK AFTER THE INITIAL IMPLANTATION OF THE MEMBRANE, THE MEMBRANE WAS GONE. TYPICAL PRODUCT RESORPTION AS INDICATED IN THE INSTRUCTIONS FOR USE IS APPROXIMATELY 8 WEEKS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7810299 ↗
Other Barrier, Animal Source, Intraoral devices
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- GIBSON HEALTHCARE 5303-306Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-342Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-324Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- Neomem N1520Collagen Matrix, Inc. · Barrier, Animal Source, Intraoral1 recall0 reports
- CopiOs Extend 0191ZCollagen Matrix, Inc. · Barrier, Animal Source, Intraoral3 reports
- SYMBIOS® USOSCRM1520Dentsply Implants Manufacturing GmbH · Barrier, animal source, intraoral3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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