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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIGN FRACTURE CARE INTERNATIONAL SIGN IM NAIL INTRAMEDULLARY FIXATION ROD

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SIGN FRACTURE CARE INTERNATIONAL SIGN IM NAIL INTRAMEDULLARY FIXATION ROD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 02/15/2016
Event Type  Injury  
Manufacturer Narrative
A product investigation was performed for this device. The actual device was not returned to the manufacturer for evaluation. The root cause of the infection and non-union is undetermined. The radiographic and clinical data were reviewed by a sign orthopedic surgeon. Sign fracture care international continues to monitor these events as part of our post market activities.
 
Event Description
We became aware on 12/08/2016, that a sign implant, implanted on (b)(6) 2014 to repair a fracture had to be removed due to infection and non-union. Surgeon comment: "patient had an infected non union right femur. Patient taken to theatre for removal of nail, debridement of infected dead bone ( 5cm bone defect created) copious lavage and a gentamycin cement spacer inserted. Ortho fix applied. ".
 
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Brand NameSIGN IM NAIL
Type of DeviceINTRAMEDULLARY FIXATION ROD
Manufacturer (Section D)
SIGN FRACTURE CARE INTERNATIONAL
451 hills street
suite b
richland WA 99354 5502
Manufacturer (Section G)
SIGN FRACTURE CARE INTERNATIONAL
451 hills street
suite b
richland WA 99354 5502
Manufacturer Contact
robert schmitt
451 hills street
suite b
richland, WA 99354-5502
5093711107
MDR Report Key6168507
MDR Text Key62182516
Report Number3034525-2016-00312
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeMI
PMA/PMN Number
K083582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 12/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received12/08/2016
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: 12/12/2016 Patient Sequence Number: 1
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