MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO-LL LUMBAR CAGE SYSTEM 8X50MMX0DEG - 22; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48942208
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	05/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon had completed insertion of cage into lumbar disc space.Wanted to put one anchor in superiorly, anchor implant bent against hard osteophyte and surgeon was forced to put anchor in inferiorly.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The most likely cause of the reported event was due to patient's very hard bone quality.
Event or Problem Description
It was reported that; surgeon had completed insertion of cage into lumbar disc space.Wanted to put one anchor in superiorly, anchor implant bent against hard osteophyte and surgeon was forced to put anchor in inferiorly.

• Brand Name: AERO-LL LUMBAR CAGE SYSTEM 8X50MMX0DEG - 22
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6638279
• Report Number: 0009617544-2017-00240
• Device Sequence Number: 849162
• Product Code: MAX
• UDI-Device Identifier: 07613327065848
• UDI-Public: (01)07613327065848
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142066
• 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): 09/19/2017

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: 48942208
• Device Catalogue Number: 48942208
• Device Lot Number: 14G558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1