MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO C CAGE 6MM INTERBODY DEVICE 12DX14W LORDOTIC; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48892066
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the blade would not go into the body and cage kept migrating interiorly.Cage was left implanted very anterior and had to use excessive malleting.2 anchors were implanted.After excessive force the blade was finally implanted.Adverse consequences remains to be seen.Patient had hard bone.
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence with the sales representative.The device was not as it remains implanted.No relevant manufacturing issues were identified as all units met stryker specifications.Due to the device not being returned, the exact root cause cannot be identified.
Event or Problem Description
It was reported that; the blade would not go into the body and cage kept migrating interiorly.Cage was left implanted very anterior and had to use excessive malleting.2 anchors were implanted.After excessive force the blade was finally implanted.Adverse consequences remains to be seen.Patient had hard bone.

• 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: 6681579
• Report Number: 0009617544-2017-00270
• Device Sequence Number: 138742
• Product Code: MAX
• UDI-Device Identifier: 07613327124651
• UDI-Public: (01)07613327124651
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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 Model Number: 48892066
• Device Catalogue Number: 48892066
• Device Lot Number: 163924
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2017
• Supplement Date Received by Manufacturer: 06/04/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 73