MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE; STAPLE

Device Problem Fracture (1260)

Patient Problem Not Applicable (3189)

Event Date 07/29/2019

Event Type  Injury  

Event Description

A doctor performed a revision surgery on (b)(6) 2019.Doctor reports that the patient has had multiple surgeries attempting fusion of multiple midfoot joints with various products.During a second surgery, doctor used 4 crossroads clips to fuse these joints, and at some point post-procedure 3 of the clips broke.Doctor performed a third surgery on (b)(6) 2019 to remove all 4 clips and to use other devices not manufactured by crossroads.

• Brand Name: DYNAFORCE
• Type of Device: STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway sutie 140; memphis TN 38119
• Manufacturer Contact: 6055 primacy parkway suite 140; memphis, TN 38119 ; 9012218406
• MDR Report Key: 8932702
• MDR Text Key: 159610733
• Report Number: 3011421599-2019-00008
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• 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 Received: 07/27/2019
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR