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

Catalog Number	48894050
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6443458
• Report Number: 0009617544-2017-00116
• Device Sequence Number: 16362551
• Product Code: MAX
• UDI-Device Identifier: 07613327124811
• UDI-Public: (01)07613327124811
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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
• Operator of Device: No Information
• Device Catalogue Number: 48894050
• Device Lot Number: 161273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1