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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE SCREW, FIXATION, BONE

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CROSSROADS EXTREMITY SYSTEMS DYNAFORCE SCREW, FIXATION, BONE Back to Search Results
Catalog Number 1406-4028
Device Problems Screw; Appropriate Term/Code Not Available
Event Date 04/10/2018
Event Type  Injury  
Manufacturer Narrative

This mdr was identified as part of complaint file remediation project. A 4. 0mm headed bone screw was removed because the patient was complaining of surface irritation. The screw was used as a lag screw across a joint in conjunction with a competitor plate for a mpj fusion. No x-ray images have been received for this case. Initial implantation date was (b)(6) 2018. Screw was removed on (b)(6) 2018. Th joint fused and the patient is not experiencing any problems. No defects were identified for the implants. Removed due to skin irritation.

 
Event Description

A revision surgery was performed to remove the bone screw due to irritation. A lag screw was placed across the joint with a plate for a mpj fusion.

 
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Brand NameDYNAFORCE
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
CROSSROADS EXTREMITY SYSTEMS
6055 primacy parkway ste 140
memphis TN 38119
Manufacturer Contact
6055 primacy parkway ste 140
memphis , TN 38119
9012218406
MDR Report Key9406494
Report Number3011421599-2019-00018
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial
Report Date 12/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number1406-4028
Device LOT Number101015
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/06/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/03/2019 Patient Sequence Number: 1
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