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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FOCAL THERAPEUTICS BIOZORB; MARKER, RADIOGRAPHIC, IMPLANTABLE
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FOCAL THERAPEUTICS BIOZORB; MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Medical Device Problem Codes Patient-Device Incompatibility (2682); Output Problem (3005)
Health Effect - Clinical Code Implant Pain (4561)
Date of Event 04/29/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Left breast lumpectomy and biozorb implant placement performed.Biozorb implant source of constant pain, requiring additional medical follow-up, pain medication and physical therapy.I also had reconstructive surgery performed on the same day by a plastic surgeon.Have large disfiguring 'divet' where the tumor was and the biozorb was placed.Both of my surgeons told me the biozorb was supposed to improve the cosmetic outcome which it failed to do.I am 6 months s/p surgery and the pain has not lessened, nor the size of the biozorb implant.I was told it would absorb in 12 months and now the breast surgeon is saying 2 years.I will probably need to have the biozorb removed leading to additional surgery and now facing mastectomy versus lumpectomy.At the very least, i am facing additional reconstructive surgery.Biozorb is such a bad product.How did it ever get approval?; fda safety report id# (b)(4).
 
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Brand Name
BIOZORB
Common Device Name
MARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
FOCAL THERAPEUTICS
MDR Report Key10860407
Report NumberMW5097946
Device Sequence Number15011740
Product Code NEU
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 11/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device No Information
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/17/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability;
Patient Age64 YR
Patient Weight68
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