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

Model Number	120-12530
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had pain and instability of the mcp joint.

• Brand Name: XMCP
• Common Device Name: 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
• Report Number: 3007289093-2022-00016
• Device Sequence Number: 6728792
• Product Code: HWC
• UDI-Device Identifier: 00842078108055
• UDI-Public: 00842078108055
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

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