MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO-LL LUMBAR CAGE SYSTEM 10X55MMX8DEG - 18; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	48941310
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	08/15/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant was used on a patient with adjacent segment disease.The anchor was approx.30% into the vertebral body when it began to bend.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: the explanted bent anchor was discarded by the hospital.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 related to overloading during impaction; the patient's hard bone quality and osteophyte.
Event or Problem Description
It was reported that the implant was used on a patient with adjacent segment disease.The anchor was approx.30% into the vertebral body when it began to bend.

• Brand Name: AERO-LL LUMBAR CAGE SYSTEM 10X55MMX8DEG - 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: 5934048
• Report Number: 0009617544-2016-00359
• Device Sequence Number: 13656690
• Product Code: MAX
• UDI-Device Identifier: 07613327068153
• UDI-Public: (01)07613327068153
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48941310
• Device Lot Number: 14G517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR