MAUDE Adverse Event Report: STRYKER SPINE-US 7MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48955076
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cage broke upon insertion in the patient.The broken pieces were retrieved and a second cage was used to complete the case with a surgical delay of five minutes.There are no reports of adverse health consequences to the patient.
Event or Problem Description
It was reported that the cage broke upon insertion in the patient.The broken pieces were retrieved and a second cage was used to complete the case with a surgical delay of five minutes.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, labelling review, risk assessment result: the reported event was confirmed upon visual inspection of the returned device.Material analysis of the device was also performed, which concluded that the device fractured in ductile overload.No material or manufacturing defects were found.Manufacturing records review did not reveal any issues.Conclusion: based on the information provided, the likely root cause of the reported cage fracture is that the disc space was too tight for the selected implant size.

• Brand Name: 7MM 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: 7392121
• Report Number: 3004024955-2018-00016
• Device Sequence Number: 1393053
• Product Code: MAX
• UDI-Device Identifier: 07613327118056
• UDI-Public: (01)07613327118056
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 48955076
• Device Catalogue Number: 48955076
• Device Lot Number: ALND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 04/03/2018
• 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