MAUDE Adverse Event Report: NEUROSTRUCTURES, LLC VARIABLE 4.0 SELF TAPPING SCREW 14MM; SPINAL INTERVERTEBRAL BODY FIXATIO ORTHOSIS

Catalog Number 10-12-014

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 06/22/2015

Event Type  Injury  

Event Description

Two distal tempus screws backed out 6-weeks post-op.

• Brand Name: VARIABLE 4.0 SELF TAPPING SCREW 14MM
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATIO ORTHOSIS
• Manufacturer (Section D): NEUROSTRUCTURES, LLC; 16 technology dr.; ste 132; irvine CA 92618
• MDR Report Key: 5053502
• MDR Text Key: 24996358
• Report Number: MW5055891
• Device Sequence Number: 2
• Product Code: KWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Report Date: 08/13/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10-12-014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR