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

Model Number 48953090

Device Problems Fracture (1260); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2018

Event Type  malfunction  

Event 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.

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 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
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7266684
• MDR Text Key: 100129098
• Report Number: 3004024955-2018-00003
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07613327117851
• UDI-Public: (01)07613327117851
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48953090
• Device Catalogue Number: 48953090
• Device Lot Number: AHJK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1