MAUDE Adverse Event Report: PRECISION SPINE, INC VAULT ALIF SELF DRILLING VARIABLE SCREW 40MM X 25MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 10-4025

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/27/2015

Event Type  Injury  

Manufacturer Narrative

Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.

Event Description

It was reported that the patient ((b)(6), female) underwent initial procedure on (b)(6), 2015, utilizing the vault alif and accufit alif systems.Subsequently, on or around (b)(6), 2015 the patient was symptomatic and radiographs identified a broken vault alif self drilling variable screw 40mm x 25mm (10-4025).Procedure was performed on or around (b)(6), 2015 to insert unilateral pedicle screws for additional stabilization.It was reported that fusion had not been achieved.

Manufacturer Narrative

Product evaluation is not possible as the fractured screw remains implanted.Two radiographs were submitted for review.These were forwarded to a medical professional for review in which it was noted that it appears that the spacer subsided and the fusion failed.Once this occurs, the screws will either loosen or fracture.Radiographs were also reviewed by engineering but nothing further was noted.Review of manufacturing history records and lot specific complaint history were not possible without lot identity.A five-year complaint history review for all part numbers in the 01-40xx family of vault alif self drilling screwsdid not reveal a trend for reports of this nature.

• Brand Name: VAULT ALIF SELF DRILLING VARIABLE SCREW 40MM X 25MM
• 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: 5224420
• MDR Text Key: 31195278
• Report Number: 3005739886-2015-00097
• 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,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 10-4025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR