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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MINIBUNION; PLATE AND SCREW
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CROSSROADS EXTREMITY SYSTEMS MINIBUNION; PLATE AND SCREW Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 07/03/2019
Event Type  Injury  
Event Description
During a follow-up visit from a bunion surgerical correction, a lateral x-ray revealed a capital fragment from the 1st metatarsal bone was fixated into place in a plantarly-displaced position.Doctor decided to perform a revision surgery to re-orient the capital fragment to a more anatomical position.The revision surgery was performed on (b)(6) 2019.
 
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Brand Name
MINIBUNION
Type of Device
PLATE AND SCREW
Manufacturer (Section D)
CROSSROADS EXTREMITY SYSTEMS
6055 primacy parkway
suite 140
memphis TN 38119
Manufacturer (Section G)
CROSSROADS EXTREMITY SYSTEMS
6055 primacy parkway
suite 140
memphis TN 38119
Manufacturer Contact
6055 primacy parkway
suite 140
memphis, TN 38119
9012218406
MDR Report Key8851178
MDR Text Key152954254
Report Number3011421599-2019-00005
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/03/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/17/2019
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;
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