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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TITANIUM BREAST MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE

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TITANIUM BREAST MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Weight Changes (2607); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/01/2020
Event Type  Injury  
Event Description
Not sure how involved there. During stereotactic needle biopsy of l breast in (b)(6) 2018, a titanium marker was implanted. Modest pain did not resolve for several months. I asked about migration, but staff knew of no such phenomena. After weight loss (20/25#) the following year, modest pain recurred sporadically with some strenuous arm muscle activity. This fall (2020), the pain changed to a sharp cut-like pain whose locus feels closer to nipple than previously. Much more frequent, painful and disruptive than previous episodes. A routine screening mammogram 2 weeks ago failed to reveal any tissue anomalies. My sense is that the marker has been migrating and has now moved into a much more nerve-dense area, triggering the sharper and more frequent pain. I don't think i can tolerate this level of recurrent pain over the long haul, so will seek removal of the device. I was given no warning about the risk of migrating, and was met with denial of any known problem with migration when i reported the problem to the provider within three months of the procedure. Fda safety report id # (b)(4).
 
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Brand NameTITANIUM BREAST MARKER
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
MDR Report Key10860718
MDR Text Key217187031
Report NumberMW5097960
Device Sequence Number1
Product Code NEU
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 11/17/2020 Patient Sequence Number: 1
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