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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFE SPINE LIFE SPINE AVATAR SCREW

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LIFE SPINE LIFE SPINE AVATAR SCREW Back to Search Results
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.
 
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Brand NameLIFE SPINE
Type of DeviceAVATAR SCREW
Manufacturer (Section D)
LIFE SPINE
13951 s. quality drive
huntley IL 60142
MDR Report Key8176253
MDR Text Key130721982
Report Number3004499989-2018-00009
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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