MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48950096
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient who was implanted with a cage in (b)(6), reported pain after the operation.It was further reported that the patient could not walk at all, a "black shadow like a foreign object" response was seen on ct images, symptoms improved as a result of block injections on the intervertebral disc and that "the intervertebral discs are doing bad things".The cage was removed on (b)(6) during a revision surgery.It was observed that the case did not fuse.After palpating the affected area, after removal, there was no cavity and normal.
Additional Manufacturer Narrative
Upon follow up it was reported that patient's pain disappeared and the patient could walk.The patient's pre-operative diagnosis was spinal canal stenosis.The reported event was confirmed via correspondence and visual inspection of the explanted cage.Materials analysis performed concludes that the cage fractured in ductile overload.The fracture origins were located along the outer surface and consistent with an overload condition.No materials or manufacturing defects were observed.The type of overload and the likely root cause could not be determined from the information provided.
Event or Problem Description
A patient who was implanted with a cage in june, reported pain after the operation.It was further reported that the patient could not walk at all, a "black shadow like a foreign object" response was seen on ct images, symptoms improved as a result of block injections on the intervertebral disc and that "the intervertebral discs are doing bad things".The cage was removed on february 23 during a revision surgery.It was observed that the case did not fuse.After palpating the affected area, after removal, there was no cavity and normal.

• Brand Name: 9MM X 6DEG X 9MM X 23MM
• 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: 7347922
• Report Number: 3004024955-2018-00013
• Device Sequence Number: 48394
• Product Code: MAX
• UDI-Device Identifier: 07613327117318
• UDI-Public: (01)07613327117318
• Combination Product (Y/N): N
• 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): 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48950096
• Device Catalogue Number: 48950096
• Device Lot Number: D0H8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 03/18/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention