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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMALL BONE INNOVATIONS, INC. STAR TOTAL ANKLE REPLACEMENT; TALAR COMPONENT
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SMALL BONE INNOVATIONS, INC. STAR TOTAL ANKLE REPLACEMENT; TALAR COMPONENT Back to Search Results
Model Number 400-251
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/10/2015
Event Type  Injury  
Event Description
Hospital implanted star total ankle talar component past sterilization expiration date.
 
Manufacturer Narrative
The dhr for part no.400-251, lot no.090604/0539.Note that 2 pieces out of (b)(4) were discarded.All released parts were within specification.Hospital implant device past serialization expiration date.
 
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Brand Name
STAR TOTAL ANKLE REPLACEMENT
Type of Device
TALAR COMPONENT
Manufacturer (Section D)
SMALL BONE INNOVATIONS, INC.
morrisville PA
Manufacturer Contact
steve ward
1380 s. pennsylvania ave.
morrisville, PA 19067
2153376481
MDR Report Key4634872
MDR Text Key5755764
Report Number3003640913-2015-00006
Device Sequence Number1
Product Code NTG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 03/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/01/2015
Device Model Number400-251
Device Lot Number090604/0539
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2012
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) Required Intervention;
Patient Age59 YR
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