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 Codes	Detachment Of Device Component (1104); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; using an implant today for a cervical fusion, one of the anchors went through the stop feature that prevents the anchor from migrating posteriorly, the doctor left as is, no replacement device was used.
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 user related-insufficient visual confirmation of the anchor's fully seated/locking.
Event or Problem Description
It was reported that; using an implant today for a cervical fusion, one of the anchors went through the stop feature that prevents the anchor from migrating posteriorly, the doctor left as is, no replacement 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: 6301226
• Report Number: 0009617544-2017-00042
• Device Sequence Number: 11014877
• Product Code: MAX
• UDI-Device Identifier: 07613327124651
• UDI-Public: (01)07613327124651
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2017

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: 48892066
• Device Lot Number: 156067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 84