MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	03805002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while impacting the cage into disc space at l3/4, the cage broke.There are no reports of adverse health consequences to the patient.
Event or Problem Description
It was reported that while impacting the cage into disc space at l3/4, the cage broke.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
The reported was confirmed via received images and visual inspection on the returned device.Manufacturing history review was performed on the reported lot# no manufacturing related issue was found.Materials analysis has been performed on the returned broken piece, which concludes that the cage fractured in ductile overload.The type of overload and the root cause of the cage fracture cannot be determined due to confounding factors.No materials or manufacturing defects were observed.Per further correspondence, the patient had a tight disc space and hard bone quality.Other patient information is not available.During the first insertion, the disc space was not distracted.In the last step of disc space sizing, the fit and feel between the trial and the disc space was tight.Surgeon turned the 8 mm trial 90degress to test the 10 mm width.Autograft bone was placed into the cage with no impaction.Heavy impacting was performed on inserter using a mallet.The implant was inserted/impacted at an angle.The 10mm cage that was broken was removed and then a 9mm cage was inserted with no issues the root cause of the reported cage fracture is likely due to oversized implant.

• Brand Name: 10MM X 6DEG X 11MM X 28MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7423296
• Report Number: 3004024955-2018-00018
• Device Sequence Number: 10802912
• Product Code: MAX
• UDI-Device Identifier: 04546540147998
• UDI-Public: (01)04546540147998
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: 03805002
• Device Catalogue Number: 48955106
• Device Lot Number: D1D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1