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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOTRACT, INC. UROLIFT IMPLANTS; IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
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NEOTRACT, INC. UROLIFT IMPLANTS; IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 02/08/2021
Event Type  malfunction  
Event Description
Had urolift procedure in february.Urologist has told me implants failed and are no longer in place.Four (4) of five (5) urolift implant devices could not be found in my body at this point in time by my urologist.Two weeks after the procedure, i knew something was wrong.Lt wasn't until a cystoscopy (requested by me) on may 4th that my surgeon said 4 of 5 implants are gone.My urologist was amazed and said he "has never seen anything like this before".My fear now is that the failed implant material may still be somewhere in my body.Urolift procedures are being performed on thousands of men across america.I also worry that my event could happen to many more men.Ultrasound was the test that showed 4 of 5 implants missing.I am now faced with trying to figure out what to do next.Will the failed implant material stay in my body somewhere and hurt me in the future? what type of procedure should i try next to alleviate my original medical condition? will new procedure be compatible with the failed implant material?.
 
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Brand Name
UROLIFT IMPLANTS
Type of Device
IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
Manufacturer (Section D)
NEOTRACT, INC.
MDR Report Key11848077
MDR Text Key251907880
Report NumberMW5101419
Device Sequence Number1
Product Code PEW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
Patient Weight76
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