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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. SALVATION EXTERNAL FIXATION SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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WRIGHT MEDICAL TECHNOLOGY, INC. SALVATION EXTERNAL FIXATION SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Back to Search Results
Model Number SEF25000
Device Problem Break (1069)
Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Event Date 02/11/2019
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
The patient has experienced external pins breaking.The patient needed to have pins replaced.
 
Manufacturer Narrative
Visual examination of the devices confirms the devices have fractured.Several of the ends of the returned devices appear to have been cut which would be consistent with implant removal techniques.
 
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Brand Name
SALVATION EXTERNAL FIXATION SYSTEM
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
MDR Report Key8412580
MDR Text Key138537617
Report Number1043534-2019-00033
Device Sequence Number1
Product Code KTT
Combination Product (y/n)N
PMA/PMN Number
K150004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSEF25000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2019
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Date Manufacturer Received09/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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