MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO C CAGE 5MM INTERBODY DEVICE, 12DX14W PARALLEL; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48892050
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while impacting the superior blade of the cage, it was being pushed posteriorly.At the time the blade locked into the cage, the posterior portion of the cage was not flush w/ the verteberbral body, as it was when the punch awls were all the way impacted.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; result: the customer reported event of cage main body migration/pull out was confirmed via correspondence.The complaint cage was still implanted.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion:since the complaint device was still implanted the root cause could not be determined conclusively.
Event or Problem Description
It was reported that while impacting the superior blade of the cage, it was being pushed posteriorly.At the time the blade locked into the cage, the posterior portion of the cage was not flush w/ the verteberbral body, as it was when the punch awls were all the way impacted.

• Brand Name: AERO C CAGE 5MM INTERBODY DEVICE, 12DX14W 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: 5699055
• Report Number: 0009617544-2016-00220
• Device Sequence Number: 11043335
• Product Code: MAX
• UDI-Device Identifier: 07613327124651
• UDI-Public: (01)07613327124651
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2016

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: 48892050
• Device Lot Number: 155721
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2016
• Supplement Report FDA Received Date: 08/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1