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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	07/27/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the blade from came out of the implant and was resting close to the patient's esophagus.
Additional Manufacturer Narrative
Method: visual analysis, device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The x-ray image is indicative of the proudness of the complaint anchor (that is, the anchor was not fully locked into the jacket).Conclusion: the most likely cause of the reported event was determined to be user related-deviation from surgical technique-anchor was not confirmed to be locked after its insertion.
Event or Problem Description
It was reported that; the blade from came out of the implant and was resting close to the patient's esophagus.

• 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: 5903384
• Report Number: 0009617544-2016-00351
• Device Sequence Number: 16307766
• Product Code: MAX
• UDI-Device Identifier: 07613327124651
• UDI-Public: (01)07613327124651
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2016
• Supplement Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention