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

Model Number	48955106
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant broke during a procedure.Part of the implant remains implanted in the patient.There was less than 20 minutes surgical delay and no adverse consequences to the patient.
Event or Problem Description
It was reported that the implant broke during a procedure.Part of the implant remains implanted in the patient.There was less than 20 minutes surgical delay and no adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event was confirmed via correspondence and received x-ray image.The cage fractured at l5/s1 during insertion, while being malleted into the disc space.Rotational force of about 5 degrees was applied.The reported cage was broken into 6 pieces and 5 were removed.One big nose (10mm) was still implanted.The five removed pieces were not returned due to hospital policy.Manufacturing history review was performed on the reported lot# and no manufacturing related issue was found.The root causes of the reported cage fracture are applied rotational overload which is deviated from the surgical technique and potential off-axial overload.

• 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: 7479072
• Report Number: 3004024955-2018-00026
• Device Sequence Number: 19230460
• 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): 09/25/2018

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: 48955106
• Device Catalogue Number: 48955106
• Device Lot Number: AM3P
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 05/02/2018
• 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