MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO C CAGE 6MM INTERBODY DEVICE, 16DX17W LORDOTIC; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48896066
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; hard bone caused almost the entire cage to back out of the space upon impacting the first anchor.So much so that the anchor fully locked into the cage but the cage was hanging out of the disc space by over 50%.Removed and used plate/peek.
Additional Manufacturer Narrative
Method:device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: since the complaint device was discarded after its removal the root cause could not be determined conclusively.
Event or Problem Description
It was reported that; hard bone caused almost the entire cage to back out of the space upon impacting the first anchor.So much so that the anchor fully locked into the cage but the cage was hanging out of the disc space by over 50%.Removed and used plate/peek.

• Brand Name: AERO C CAGE 6MM INTERBODY DEVICE, 16DX17W 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: 5640871
• Report Number: 0009617544-2016-00174
• Device Sequence Number: 18971216
• Product Code: OVD
• UDI-Device Identifier: 07613327124842
• UDI-Public: (01)07613327124842
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2016

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: 48896066
• Device Lot Number: 155739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2016
• Supplement Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR