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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. BIOFOAM BONE WEDGE PLATE, FIXATION, BONE

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WRIGHT MEDICAL TECHNOLOGY, INC. BIOFOAM BONE WEDGE PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Literature citation: moore et al. Porous titanium wedges in lateral column lengthening for adult-acquired flatfoot deformity. Foot & ankle specialist. 2017. Patient info: 2 female - 64 and 21 years; 3 male - 19, 64, 35 years. Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
Event Description
Allegedly, in an article titled, "porous titanium wedges in lateral column lengthening for adult-acquired flatfoot deformity" written by moore et al. It was reported that patients underwent surgery with the use of porous titanium wedges. 5 patients developed joint paint. The pain was significant enough in 3 patients to warrant steroid injection. Of these 3 patients, 1 received an evans wedge and 2 received cotton wedges. The patient with the evans wedge was the only one in the cohort to develop radiographic signs of cc joint arthritis (2. 9%). The first of the 2 feet with a cotton wedge to require a cc joint injection was a patient who developed worsening of their midfoot sag present preoperatively. Their deformity was primarily through the naviculocuneiform joint and led to significant midfoot arthritis. The second of the 2 feet had no signs of arthritis and required a second steroid injection for pain control, but subsequently improved without further complication.
 
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Brand NameBIOFOAM BONE WEDGE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
matthew parrish
1023 cherry rd
memphis, TN 38117
MDR Report Key9012731
MDR Text Key161355319
Report Number1043534-2019-00122
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/12/2019 Patient Sequence Number: 1
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