MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. XMCP; BONE SCREW

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 08/27/2019

Event Type  malfunction  

Event Description

It was reported that the lag "acrew" loosened in the xmcp construct and the patient had a revisions surgery to place a longer lag screw.

• Brand Name: XMCP
• Type of Device: BONE SCREW
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; suite 410; parsippany NJ 07054
• Manufacturer Contact: brian smekal ; 300 interpace parkway; suite 410; parsippany, NJ 07054 ; 9735888980
• MDR Report Key: 9335914
• MDR Text Key: 189491609
• Report Number: 3007289093-2019-00020
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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