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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. ORTHOLOC 3DI PLATE, FIXATION, BONE

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WRIGHT MEDICAL TECHNOLOGY, INC. ORTHOLOC 3DI PLATE, FIXATION, BONE Back to Search Results
Catalog Number 5920103L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Swelling (2091)
Event Date 02/17/2016
Event Type  Injury  
Manufacturer Narrative
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
It was reported that the patient underwent an ankle fusion surgery with a plating system. Allegedly, the patient had swelling 8 months post-op.
 
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Brand NameORTHOLOC 3DI
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington, tn
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington, tn
Manufacturer Contact
matthew parrish
1023 cherry rd
memphis, tn 
MDR Report Key10088224
MDR Text Key192027444
Report Number1043534-2020-00100
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number5920103L
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 Received04/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/26/2020 Patient Sequence Number: 1
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