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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAND BIOMECHANICS LAB, INC. TURNKEY FCS
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HAND BIOMECHANICS LAB, INC. TURNKEY FCS Back to Search Results
Model Number FCS-400
Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
Reviewed sterilization and sterile barrier inspection records for lot.No pattern related to irradiation dose lot or device lot was noted.Confirmed labeling included cautions regarding pin site care.
 
Event Description
Patient had surgery to install a turnkey fcs external fixation device.Physician reported device was removed 3 weeks post operative because of a pin site infection.
 
Event Description
Patient had surgery to install a turnkey fcs external fixation device.Physician reported device was removed 3 weeks post operative because of a pin site infection.
 
Manufacturer Narrative
Reviewed sterilization and sterile barrier inspection records for lot.No pattern related to irradiation dose lot or device lot was noted.Confirmed labeling included cautions regarding pin site care.
 
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Brand Name
TURNKEY FCS
Type of Device
TURNKEY FCS
Manufacturer (Section D)
HAND BIOMECHANICS LAB, INC.
77 scripps drive, suite 104
sacramento CA 95825
MDR Report Key7437849
MDR Text Key105755540
Report Number2919128-2018-00008
Device Sequence Number1
Product Code JEC
Combination Product (y/n)N
PMA/PMN Number
K072432
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/27/2018
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 NumberFCS-400
Device Catalogue NumberFCS-400
Device Lot NumberFXD-108-199
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/04/2008
Initial Date FDA Received04/17/2018
Supplement Dates Manufacturer Received12/04/2008
Supplement Dates FDA Received12/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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