MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO C CAGE 6MM INTERBODY DEVICE 12DX14W LORDOTIC; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48892066
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the insertion of the implant, the blade/ anchor would not advance.The surgeon was forcibly malleting the anchor tamp and the blade would not advance into the superior vertebral body (c5).The entire device had to be removed using the removal tool and an alternate device was used.
Additional Manufacturer Narrative
Method: visual inspection; material analysis; device history review; complaint history review; risk assessment.Results: the returned device was confirmed to be jammed upon visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: the root cause cannot determined based on the materials analysis but the lack of position downward pressure on the inserter during insertion of the pilot cutter could be a contributing factor.
Event or Problem Description
It was reported that during the insertion of the implant, the blade/ anchor would not advance.The surgeon was forcibly malleting the anchor tamp and the blade would not advance into the superior vertebral body (c5).The entire device had to be removed using the removal tool and an alternate device was used.

• Brand Name: AERO C CAGE 6MM INTERBODY DEVICE 12DX14W LORDOTIC
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5489814
• Report Number: 0009617544-2016-00106
• Device Sequence Number: 498458
• Product Code: MAX
• UDI-Device Identifier: 07613327124651
• UDI-Public: (01)07613327124651
• 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): 02/12/2016

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: 48892066
• Device Lot Number: 155716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 05/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR