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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FOCAL THERAPEUTICS / HOLOGIC, INC. HOLOGIC BIOZORB MARKER / BIOZORB IMPLANT MARKER, RADIOGRAPHIC, IMPLANTABLE

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FOCAL THERAPEUTICS / HOLOGIC, INC. HOLOGIC BIOZORB MARKER / BIOZORB IMPLANT MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number F0202
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2021
Event Type  malfunction  
Event Description
During a left lumpectomy revision on (b)(6) 2021, the biozorb implanted on (b)(6) 2020 was distorted, removed, & a new implant placed. "the biozorb was discarded. " fda safety report id# (b)(4).
 
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Brand NameHOLOGIC BIOZORB MARKER / BIOZORB IMPLANT
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
FOCAL THERAPEUTICS / HOLOGIC, INC.
sunnyvale CA 94085
MDR Report Key11421954
MDR Text Key238403575
Report NumberMW5099809
Device Sequence Number1
Product Code NEU
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF0202
Device Lot NumberA1-200706
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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