MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 14; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number 48811114

Device Problems Mechanical Problem (1384); Material Deformation (2976); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2017

Event Type  malfunction  

Event Description

It was reported that 14mm plate locking mechanism fell off the track on locking and was protruding.

Manufacturer Narrative

Visual inspection, device history review, complaint history review, risk assessment.The device was confirmed to have a deformed spring bar.Manufacturing files were reviewed and no anomalies were found.Potential root causes include: excessive torsional force/cantilever force applied, screw not fully seated below spring-bar, screw inserted outside of design range, stripped screw head/screwdriver tip.

Event Description

It was reported that 14mm plate locking mechanism fell off the track on locking and was protruding.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 14
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6501563
• MDR Text Key: 73241613
• Report Number: 0009617544-2017-00157
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152118
• UDI-Public: (01)07613252152118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48811114
• Device Catalogue Number: 48811114
• Device Lot Number: 164516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: 03/24/2017
• Supplement Dates FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2016
• 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