MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO-LL LUMBAR CAGE SYSTEM 10X50MMX0DEG - 18; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	48940210
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon insertion of first aero-ll blade, it would not seat and resistance increased.The doctor took x-ray and noticed the blade was now curved and not attached to the front rail.Decided to try and remove and was unsuccessful at initial attempt.Eventually removed enough bone to pull the blade out.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the device deformation was confirmed via x-ray film and correspondence.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the reported event was determined to be patient's very sclerotic bone quality.
Event or Problem Description
It was reported that upon insertion of first aero-ll blade, it would not seat and resistance increased.The doctor took x-ray and noticed the blade was now curved and not attached to the front rail.Decided to try and remove and was unsuccessful at initial attempt.Eventually removed enough bone to pull the blade out.

• Brand Name: AERO-LL LUMBAR CAGE SYSTEM 10X50MMX0DEG - 18
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5567837
• Report Number: 0009617544-2016-00144
• Device Sequence Number: 16205575
• Product Code: MAX
• UDI-Device Identifier: 07613327065718
• UDI-Public: (01)07613327065718
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/14/2016

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: 48940210
• Device Lot Number: 14G547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2016
• Supplement Report FDA Received Date: 06/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR