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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIGN FRACTURE CARE INTERNATIONAL STANDARD IM NAIL; INTRAMEDULLARY ROD
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SIGN FRACTURE CARE INTERNATIONAL STANDARD IM NAIL; INTRAMEDULLARY ROD Back to Search Results
Model Number STANDARD IM NAIL
Device Problem Failure to Osseointegrate (1863)
Patient Problem Non-union Bone Fracture (2369)
Event Date 04/23/2014
Event Type  Injury  
Event Description
Reviewed surgeons database report which stated that follow up on a patient found a non-union of a fracture with an im nail implanted.The surgeon performed an exchange nail procedure to repair the fracture and replace the nail.Review of the patient x-rays confirms the non-union and the new im nail.No breakage was noted on the nail or no indication of product defect.
 
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Brand Name
STANDARD IM NAIL
Type of Device
INTRAMEDULLARY ROD
Manufacturer (Section D)
SIGN FRACTURE CARE INTERNATIONAL
richland WA 99354
Manufacturer Contact
doug donnelly
451 hills street, suite b
richland, WA 99354
5093761107
MDR Report Key3800247
MDR Text Key20659503
Report Number3034525-2014-00025
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K022632
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Physician
Remedial Action Replace
Type of Report Initial
Report Date 04/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberSTANDARD IM NAIL
Device Catalogue NumberSTANDARD IM NAIL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/24/2014
Initial Date FDA Received04/30/2014
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 Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age35 YR
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