MAUDE Adverse Event Report: ARTHROSTIM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 06/02/2016

Event Type  Injury  

Event Description

The product is called an arthrostim instrument and it is injuring people.It is being sold to chiropractors.It is a mechanized metal instrument with attachments that strike very hard and fast while the finger is holding the trigger.The attachments are made of hard plastic.It is being advertised to use on the cervical vertebrae, particularly the atlas and axis.I only know of medical doctors to use mechanized equipment to treat the cervical vertebrae (equipment which has gone through thorough medical trials) not chiropractors, and i feel this device is illegal.I believe a chiropractor intentionally injured me by using this device which is why i reported the incident to my local police department.(b)(4).

• Brand Name: ARTHROSTIM
• Type of Device: ARTHROSTIM
• MDR Report Key: 5735905
• MDR Text Key: 47827219
• Report Number: MW5062922
• Device Sequence Number: 1
• Product Code: LXM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 32 YR
• Patient Weight: 77