MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 0DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48953090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
After a cage was inserted (l5-s1), final x-ray indicated the cage split.The surgeon removed the posterior portion of the cage, leaving anterior portion in the disc space.All fragments were successfully retrieved and there were no delays or adverse health consequences to the patient.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: the reported event of was confirmed via email correspondence with the sales rep.The device was not returned.The explanted posterior portion was discarded by the hospital.The anterior portion is still implanted.Manufacturing history review was performed on the reported lot# no manufacturing related issue was found.Conclusion: the root cause of the reported event cannot be determined due to lack of information.Following are the potential factors that might be leading to the intra-op fractures.Thickness of wall adjacent to lateral window.Size of lateral window.User overestimating strength of implant and applying excessive force (torsional, cantilever).Not following surgical technique guide; using oversized implant or wrong type/size of inserter, not distracting when inserting or repositioning, use of ¿twist & distract¿ method.
Event or Problem Description
After a cage was inserted (l5-s1), final x-ray indicated the cage split.The surgeon removed the posterior portion of the cage, leaving anterior portion in the disc space.All fragments were successfully retrieved and there were no delays or adverse health consequences to the patient.

• Brand Name: 9MM X 0DEG 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: 7266684
• Report Number: 3004024955-2018-00003
• Device Sequence Number: 16405150
• Product Code: MAX
• UDI-Device Identifier: 07613327117851
• UDI-Public: (01)07613327117851
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• 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: No Information
• Device Model Number: 48953090
• Device Catalogue Number: 48953090
• Device Lot Number: AHJK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 02/13/2018
• 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