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

Model Number	48955166
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cage was implanted during l4-5 tlif procedure on (b)(6) 2016.The procedure was completed successfully with no inter-operative complications.Upon regular follow up with the patient and review of post operative ct scan, it was noticed that whilst the patient had fused and had no post operative complications/symptoms, the implanted cage had several points of fracture.
Event or Problem Description
It was reported that a cage was implanted during l4-5 tlif procedure on (b)(6) 2016.The procedure was completed successfully with no inter-operative complications.Upon regular follow up with the patient and review of post operative ct scan, it was noticed that whilst the patient had fused and had no post operative complications/symptoms, the implanted cage had several points of fracture.
Additional Manufacturer Narrative
Method: product history review, complaint history review, labelling review, risk assessment.Result: the reported event was confirmed via correspondence with the representative and review of post-op x-ray images.The device was not returned as it is in possession of the patient and cannot be released, thus inspection cannot be completed.Manufacturing review was completed for this device, and no issues were found.Conclusion: as the device was not returned, a definite root cause cannot be determined.Possible root causes include excessive patient post-op activity and patient non-fusion.If the device is made available in the future it will be investigated.

• Brand Name: 11MM 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: 7328821
• Report Number: 3004024955-2018-00010
• Device Sequence Number: 41040
• Product Code: MAX
• UDI-Device Identifier: 07613327118148
• UDI-Public: (01)07613327118148
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K160955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• 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: Health Professional
• Device Model Number: 48955166
• Device Catalogue Number: 48955116
• Device Lot Number: AAEY
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 03/09/2018
• 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
• Patient Age: 82 YR