MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO C CAGE 5MM INTERBODY DEVICE, 14DX15W PARALLEL; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48894050

Device Problems Disassembly (1168); Difficult to Insert (1316)

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

Event Date 03/01/2017

Event Type  malfunction  

Event Description

It was reported that; the anchor of the cage would not fully insert into bone.The pilot cutter would not seat all the way into bone either.The surgeon attempted to drive the cutter several times and we tried multiple different pilot cutters.Then he attempted to drive the anchor into vertebral body and it stopped after driving through bone approximately 85% of the way.We attempted several different tamps as well as the free hand tamp.After trying for 5-10 minutes the surgeon was not willing to apply any more force via malleting the anchor.The surgeon was malletting at a force greater than normal for cervical implant placement.The blade was left without being fully inserted.The associated surgical delay was 15 minutes.

Manufacturer Narrative

Device history review, complaint history review, risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The most likely cause of the reported event is related to (1) the pilot cutter didn't creat the channel with enough length so that the anchor can go through; (2) possible local hard patient bone related to the patient's disc herniation.

Event Description

It was reported that; the anchor of the cage would not fully insert into bone.The pilot cutter would not seat all the way into bone either.The surgeon attempted to drive the cutter several times and we tried multiple different pilot cutters.Then he attempted to drive the anchor into vertebral body and it stopped after driving through bone approximately 85% of the way.We attempted several different tamps as well as the free hand tamp.After trying for 5-10 minutes the surgeon was not willing to apply any more force via malleting the anchor.The surgeon was malleting at a force greater than normal for cervical implant placement.The blade was left without being fully inserted.The associated surgical delay was 15 minutes.

• Brand Name: AERO C CAGE 5MM INTERBODY DEVICE, 14DX15W PARALLEL
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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: 6443458
• MDR Text Key: 71465243
• Report Number: 0009617544-2017-00116
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07613327124811
• UDI-Public: (01)07613327124811
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48894050
• Device Lot Number: 161273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2016
• 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