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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. DARCO® PLATE, FIXATION, BONE

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WRIGHT MEDICAL TECHNOLOGY, INC. DARCO® PLATE, FIXATION, BONE Back to Search Results
Model Number DCS2825014
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/06/2018
Event Type  malfunction  
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
Allegedly, the screw went through the plate during insertion. The screw was unable to be retrieved from the patient and remained fully intact in the patient. The surgery was carried out with 3 screws fixated on the plate.
 
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Brand NameDARCO®
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
38002
Manufacturer Contact
1023 cherry road
901451-631
MDR Report Key7490175
MDR Text Key107464584
Report Number1043534-2018-00033
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K061808
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDCS2825014
Device Lot Number1600305
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/09/2018
Event Location Hospital
Date Manufacturer Received04/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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