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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND CP IMPLANT SYSTEM; PLATE, FIXATION, BONE
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CROSSROADS EXTREMITY SYSTEMS MOTOBAND CP IMPLANT SYSTEM; PLATE, FIXATION, BONE Back to Search Results
Model Number 270306
Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)
Patient Problem Implant Pain (4561)
Event Type  malfunction  
Event Description
The surgeon identified a broken himax staple in a motoband cp staple plate construct at routine follow-up.The devices were explanted and returned to crossroads.
 
Manufacturer Narrative
The surgeon identified a broken himax staple in a motoband cp staple plate construct at routine follow-up.The devices were explanted and returned to crossroads.Examination of the plate and staple fracture were consistent with fatigue fracture.
 
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Brand Name
MOTOBAND CP IMPLANT SYSTEM
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
CROSSROADS EXTREMITY SYSTEMS
6423 shelby view dr.
suite 101
memphis TN 38134
Manufacturer Contact
6423 shelby view dr.
suite 101
memphis, TN 38134
9012218406
MDR Report Key13980755
MDR Text Key290449420
Report Number3020584246-2022-00001
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K193452
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 12/07/2021
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 Number270306
Device Lot Number20202591
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/08/2022
Initial Date FDA Received04/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2019
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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