MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE HIMAX; STAPLE

Catalog Number 7115-1515KT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Lupus (1956)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

The nitinol clip listed previously was used in conjunction with the implants listed below as a total construct for bone fragment osteotomy fixation and joint arthrodesis.Component implants used in entire construct: motoband cp non-locking screw 3.5mm x 30mm part #: 1500-3530 lot #: 500208; motoband cp locking screw 3.5mm x 30mm part #: 15lk-3530 lot #: 500316; motoband max z alpha plate 15mm part #: 7100-za15 lot #: 500263.

Event Description

Doctor performed a talo-navicular fusion using crossroads plate, screws, and staple construct.Patient has lupus, diabetes, diabetic neuropathy, mueller weiss syndrome, and developed charcot foot after this operation.Doctor says that the patient experienced complete fusion 3 months after surgery, and then the patient develops charcot foot.Doctor reports that everything collapsed, and one leg of the staple and 1 screw broke.

• Brand Name: DYNAFORCE HIMAX
• Type of Device: STAPLE
• 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 Key: 9134475
• MDR Text Key: 162373961
• Report Number: 3011421599-2019-00010
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K160300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 7115-1515KT
• Device Lot Number: 300028
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR