MAUDE Adverse Event Report: STRYKER SPINE-US 12MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48955126
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inserting a cage (l4/5) with the correct inserter, it broke in the middle of the cage.The cage was about half way in when the surgeon tried to slightly rotate the cage to obtain better alignment.When the next x-ray was taken, it was noticed that the cage had fractured down the middle.The cage was left in as is.There are no reports of adverse consequences to the patient.
Event or Problem Description
It was reported that while inserting a cage (l4/5) with the correct inserter, it broke in the middle of the cage.The cage was about half way in when the surgeon tried to slightly rotate the cage to obtain better alignment.When the next x-ray was taken, it was noticed that the cage had fractured down the middle.The cage was left in as is.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Method: product history review, complaint history review, labelling review, risk assessment.Result: the reported event of was confirmed via correspondence.The cage fractured at l4/l5 when rotational force was applied.Manufacturing history review was performed on the reported lot# no manufacturing related issue was found.The device was not returned for evaluation as it remains implanted.Conclusion: the root cause of the reported cage fracture is the applied rotational overload which deviates from the surgical technique.

• Brand Name: 12MM 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: 7479030
• Report Number: 3004024955-2018-00024
• Device Sequence Number: 16171170
• Product Code: MAX
• UDI-Device Identifier: 07613327118100
• UDI-Public: (01)07613327118100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• 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): 09/28/2018

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: Health Professional
• Device Model Number: 48955126
• Device Catalogue Number: 48955126
• Device Lot Number: DMN1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 05/02/2018
• 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
• Patient Weight: 124