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

Catalog Number	48942208
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pilot cutter and the cage blade bent, used a replacement device.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment.Result: the customer reported event was confirmed via x-ray film and correspondence.The anchor was not returned because it was thrown into the sharps 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 patient's extremely hard bone quality, however, the deformed anchor was not returned for evaluation and therefore the exact root cause could not be determined.
Event or Problem Description
It was reported that the pilot cutter and the cage blade bent, used a replacement device.

• 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: 5753072
• Report Number: 0009617544-2016-00253
• Device Sequence Number: 16308003
• Product Code: MAX
• UDI-Device Identifier: 07613327065848
• UDI-Public: (01)07613327065848
• Combination Product (Y/N): N
• 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): 06/02/2016

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: 48942208
• Device Lot Number: 14G558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2016
• Supplement Report FDA Received Date: 09/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1