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

Model Number	48892050
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the cutter would not penetrate bone.In response the cage kept getting forced out of the disc space.
Additional Manufacturer Narrative
Results: visual, dimensional and functional analysis could not be performed as the device is still implanted.No relevant manufacturing issues were identified as all units met stryker specifications.Conclusion: based on the correspondence with sales rep.The root cause of the cage displacement during pilot cutter insertion is likely due to too much applied impaction force and patient's hard bone quality.
Event or Problem Description
It was reported that; the cutter would not penetrate bone.In response the cage kept getting forced out of the disc space.

• 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: 6989415
• Report Number: 0009617544-2017-00387
• Device Sequence Number: 498018
• Product Code: MAX
• UDI-Device Identifier: 07613327124675
• UDI-Public: (01)07613327124675
• 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): 01/17/2018

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 Model Number: 48892050
• Device Catalogue Number: 48892050
• Device Lot Number: 161251
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 68