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

Model Number 120-12530

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Joint Laxity (4526); Implant Pain (4561)

Event Date 11/18/2022

Event Type  Injury  

Event Description

It was reported that a patient had pain and instability of the mcp joint.

• 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: 16283520
• MDR Text Key: 308630102
• Report Number: 3007289093-2022-00016
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00842078108055
• UDI-Public: 00842078108055
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 120-12530
• Device Catalogue Number: 120-12530
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention