MAUDE Adverse Event Report: PRECISION SPINE, INC VAULT ALIF SELF DRILLING VARIABLE SCREW; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 10-40XX

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation was not possible as the product remains implanted.Manufacturing history review and lot specific complaint history were not possible without lot identification.Review of complaint history for all part numbers in the 10-40xx family of vault alif self drilling variable screws did not identify a trend for reports of this nature.Based on the information provided, no conclusions can be drawn as to the cause of the reported screw breakage.

Event Description

The patient underwent initial procedure utilizing the vault alif system on (b)(6) 2016.Subsequently, dr.(b)(6) saw the patient in clinic on (b)(6) 2017 where it was identified that one of the vault alif self drilling variable screws located at s1 had broken.There is no plan at this time to perform surgery to remove the broken screw.

• Brand Name: VAULT ALIF SELF DRILLING VARIABLE SCREW
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: beth albert ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 6344270
• MDR Text Key: 68142681
• Report Number: 3005739886-2017-00006
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 10-40XX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: No
• 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