MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO C CAGE 7MM INTERBODY DEVICE, 14DX15W LORDOTIC; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48894076
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	01/31/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; cage was implanted at c3-4 to flush with vb.Pilot cutter was used as outlined in technique.Anchor was placed in channel.Upon impaction, cage migrated anteriorly about 3mm with the blade locking into the cage.Confirmed on lateral fluoroscopy.Entire construct was malleted into place.Second anchor was inserted without any trouble.Cage remains 1mm proud.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment.Manufacturing review of the device was performed and indicated no discrepancies or anomalies.Visual, dimensional and functional analysis could not be performed as the device was still implanted.The root cause could not be determined conclusively.
Event or Problem Description
It was reported that; cage was implanted at c3-4 to flush with vb.Pilot cutter was used as outlined in technique.Anchor was placed in channel.Upon impaction, cage migrated anteriorly about 3mm with the blade locking into the cage.Confirmed on lateral fluoroscopy.Entire construct was malleted into place.Second anchor was inserted without any trouble.Cage remains 1mm proud.

• Brand Name: AERO C CAGE 7MM INTERBODY DEVICE, 14DX15W 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: 6358172
• Report Number: 0009617544-2017-00062
• Device Sequence Number: 10773532
• Product Code: MAX
• UDI-Device Identifier: 07613327124866
• UDI-Public: (01)07613327124866
• 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): 04/27/2017

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: 48894076
• Device Lot Number: 156077
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR