MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE STEP STAPLE; PLATE, FIXATION, BONE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

A revision to step staple was reported.No additional details are available.If additional information is available, this report will be updated.

Event Description

A revision to step staple was reported.No additional details are available.If additional information is available, this report will be updated.

• Brand Name: DYNAFORCE STEP STAPLE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis, tn
• Manufacturer Contact: 6055 primacy parkway ste 140; memphis, tn ; 2218406
• MDR Report Key: 10097286
• MDR Text Key: 193428327
• Report Number: 3011421599-2020-00010
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K181866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• 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: 04/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention