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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 3-D LAPIPLASTY BUNION DEFORMITY CORRECTION; PLATE, FIXATION, BONE
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TREACE MEDICAL CONCEPTS, INC. 3-D LAPIPLASTY BUNION DEFORMITY CORRECTION; PLATE, FIXATION, BONE Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Fall (1848); Pain (1994); Ambulation Difficulties (2544); Limb Fracture (4518); Implant Pain (4561)
Event Date 08/07/2020
Event Type  Injury  
Event Description
On (b)(6) 2020 i had an outpatient procedure to correct my bunion undergoing a "3-d lapiplasty" advertised by treace co (b)(6).Since that date i have suffered from worse pain in my foot than prior to surgery.The pain is constant when ambulating, along the area of where i believe the surgical hardware was implanted.As a result of this ongoing pain and interference with ambulation i suffered a serious fall fracturing my distal radius bone, surgery, and implant of plates, pins and screws in my arm.I have had numerous (> 30) physical therapy appts to improve the foot pain to no avail.The pain is worse than before my surgery and interferes with my enjoying things i did prior to the bunion surgery.I believe that this procedure needs to be investigated by the fda.I question the authenticity of what they advertise and inform the patient about.I am suspect that the surgical hardware is the culprit in my case along with an "overcorrection" of bone placement intra-operatively.Fda safety report id# (b)(4).
 
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Brand Name
3-D LAPIPLASTY BUNION DEFORMITY CORRECTION
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
TREACE MEDICAL CONCEPTS, INC.
MDR Report Key11701720
MDR Text Key246795989
Report NumberMW5100910
Device Sequence Number1
Product Code HRS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Age65 YR
Patient Weight79
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