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

Model Number	48955106
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inserting the pl cage with the correct inserter, it broke in the middle.The nose of the cage was just inside the disc space when the surgeon rotated the cage about 20 degrees to obtain better insertion alignment.When the next x-ray was taken, it was noticed that the cage had fractured down the middle.All pieces of the cage were removed.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, materials analysis, product history review, complaint history review, labelling review, risk assessment.Result: the reported event was confirmed via correspondence and visual inspection of the returned device.The cage fractured at l5/s1 when rotational force was applied.After removing the broken cage, another cage with the same size was successfully implanted without applying rotational force.Per surgical technique, the rotational force was not recommended to be applied for cage insertion.Manufacturing history review was performed on the reported lot# and no manufacturing related issue was found.Materials analysis has been performed and concludes that the cage fractured in ductile overload, through rotational force.No materials or manufacturing defects were observed.Conclusion: the root cause of the reported cage fracture is the applied rotational overload which is deviated from the surgical technique.
Event or Problem Description
It was reported that while inserting the pl cage with the correct inserter, it broke in the middle.The nose of the cage was just inside the disc space when the surgeon rotated the cage about 20 degrees to obtain better insertion alignment.When the next x-ray was taken, it was noticed that the cage had fractured down the middle.All pieces of the cage were removed.There are no reports of adverse consequences to the patient.

• 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: 7482350
• Report Number: 3004024955-2018-00028
• Device Sequence Number: 1950074
• Product Code: MAX
• UDI-Device Identifier: 07613327118087
• UDI-Public: (01)07613327118087
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: 48955106
• Device Catalogue Number: 48955106
• Device Lot Number: D3NN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1