MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X 9MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48954096
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon insertion of the cage at the l5-s1 level broke in two pieces as the cage was advancing into the disc space.The surgeon was following correct insertion guidelines and was not handling it aggressively or using excessive force.The surgeon was able to distract the disc space enough to retrieve the broken piece and he then placed another cage of the same size into the space with no issues.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
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.Based on the information provided, the likely root cause of the reported cage fracture is off-axial overload.
Event or Problem Description
It was reported that upon insertion of the cage at the l5-s1 level broke in two pieces as the cage was advancing into the disc space.The surgeon was following correct insertion guidelines and was not handling it aggressively or using excessive force.The surgeon was able to distract the disc space enough to retrieve the broken piece and he then placed another cage of the same size into the space with no issues.There are no reports of adverse consequences to the patient.

• Brand Name: 9MM X 6DEG X 9MM 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: 7410612
• Report Number: 3004024955-2018-00017
• Device Sequence Number: 19105951
• Product Code: MAX
• UDI-Device Identifier: 07613327117967
• UDI-Public: (01)07613327117967
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• 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: No Information
• Device Model Number: 48954096
• Device Catalogue Number: 48954096
• Device Lot Number: D4P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 04/10/2018
• 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