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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
Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
The reporter states that the screw has backed out and provide an x-ray with the screw back-out using a dynaforce lz plate.The surgeon was not able to provide additional information regarding the case such as original surgery date or follow-up timeframe of the x-ray as the surgeon has changed practices.The surgeon did not report that the patient was revised.
 
Event Description
The reporter states that the screw has backed out and provide an x-ray with the screw back-out using a dynaforce lz plate.The surgeon was not able to provide additional information regarding the case such as original surgery date or follow-up timeframe of the x-ray as the surgeon has changed practices.The surgeon did not report that the patient was revised.
 
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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 Key15501699
MDR Text Key306264117
Report Number3020584246-2022-00054
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 Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 09/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received04/09/2021
Was Device Evaluated by Manufacturer? No
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) Other;
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