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

Model Number	130-65050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Axis beam removal due to infection.

• Brand Name: AXIS
• Common Device Name: BONE SCREW
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC; 300 interpace parkway; building a, 2nd floor; parsippany NJ 07054
• Manufacturer Contact: brian smekal ; 300 interpace parkway; building a, 2nd floor; parsippany, NJ 07054 ; 9735888988
• MDR Report Key: 17320598
• Report Number: 3007289093-2023-00006
• Device Sequence Number: 6573447
• Product Code: HWC
• UDI-Device Identifier: 00842078113158
• UDI-Public: 00842078113158
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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: 130-65050
• Device Catalogue Number: 130-65050
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 07/13/2023
• 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 Age: 36 YR
• Patient Sex: Female