MAUDE Adverse Event Report: PRECISION SPINE, INC VAULT ALIF SELF DRILLING VARIABLE SCREW 40MM X 35MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 10-4035

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation was not possible as the product remains implanted.Lot number cannot be determined.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.No conclusion can be drawn with the information available at this time.Should additional information be received that changes the outcome of the investigation a follow-up medwatch report will be filed.

Event Description

The patient underwent and alif procedure on (b)(6) 2016, subsequently, during a routine follow up exam on (b)(6) 2016, x-ray revealed two broken vault alif self drilling variable screws 40mm x 35mm (10-4035).No revision procedure has been performed at this time.

• Brand Name: VAULT ALIF SELF DRILLING VARIABLE SCREW 40MM X 35MM
• 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 dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 6403978
• MDR Text Key: 70199629
• Report Number: 3005739886-2017-00014
• 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: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 10-4035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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