MAUDE Adverse Event Report: LIFE SPINE LIFE SPINE; AVATAR SCREW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 07/10/2017

Event Type  Injury  

Manufacturer Narrative

After mdr report mw5080727 was "recieved" it was determined that life spine only supplied the screws not the cage or bone graft.The mdr event description appears that there was an issue with the cage implant being too small and the graft material falling out of the cage implant.However, the mdr mw5080727 isn't clear when the screws became loose, after the first surgery or the revision surgery, so it is hard to determine why or when the screws became loose.Also without "recieiving" the screws back we are unable to determine if the screws even had issues or if it was user error.

Event Description

Life spine "recieved" an fda report mw5080727, in the report it stated that a patient had an adverse event where an interbody cage, screws and bone graft material was used.It was noted in the report that all of the products were life spine products.However, after life spine investigated the only life spine products that were used were the screws.There was never a complaint logged with life spine or a return of the screws.

• Brand Name: LIFE SPINE
• Type of Device: AVATAR SCREW
• Manufacturer (Section D): LIFE SPINE; 13951 s. quality drive; huntley IL 60142
• MDR Report Key: 8176253
• MDR Text Key: 130721982
• Report Number: 3004499989-2018-00009
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1