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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

It was reported that a patient with motoband cp plates, screws and dynaforce clips underwent revisions approximately 1 year post-operatively.No patient specific information has been provided at this time for further investigation.As additional information is provided, this report will be updated.

Event Description

It was reported that a patient with motoband cp plates, screws and dynaforce clips underwent revisions approximately 1 year post-operatively.No patient specific information has been provided at this time for further investigation.As additional information is provided, this report will be updated.

• Type of Device: STAPLE, 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: 9880408
• MDR Text Key: 200647424
• Report Number: 3011421599-2020-00006
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• 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