MAUDE Adverse Event Report: VGI MEDICAL, LLC VERTELP; LATERAL INTERBODY, PRODUCT CODE OVD

Model Number VG-LP-18X50X10(7)

Device Problems Fracture (1260); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

Device not returned to company.

Event Description

Post-op x-ray revealed a broken screw used to actuate the integrated fixation of the implant.

• Brand Name: VERTELP
• Type of Device: LATERAL INTERBODY, PRODUCT CODE OVD
• Manufacturer (Section D): VGI MEDICAL, LLC; 10401 belcher road; largo FL 33777
• Manufacturer (Section G): VGI MEDICAL, LLC; 10401 belcher road; largo FL 33777
• Manufacturer Contact: tracy gulick ; 10401 belcher road; largo, FL 33777 ; 7275651235
• MDR Report Key: 6529749
• MDR Text Key: 74086347
• Report Number: 3006982954-2016-00001
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VG-LP-18X50X10(7)
• Device Catalogue Number: VG-LP-18X50X10(7)
• Device Lot Number: 131722-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/25/2016
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR