MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48950096
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after intra-operative placement of a tritanium pl cage, the surgeon decided to change the cage size.During removal of the cage with the inserter, the cage fractured and part of it remained inside the patient while the other part came out.The fractured cage was left in the patient and the intervertebral space was packed with autologous bone to prevent it from moving.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Visual inspection: the proximal end of the implant containing the threaded section was returned.It was fractured off from the main portion of the implant.The device and complaint history records were reviewed, no relevant manufacturing issues or similar complaints were identified.It was reported that the disc space was expanded using distractors and reamers and the cage was inserted straight with the standard inserter.The surgeon then decided to change the cage size and released compression.When the surgeon tried to remove the cage using the inserter, the solid part at the tip remained inside the body and only a part of the cage came out.Removal of the cage was then attempted with the same inserter.It is unknown if trialing occurred, if the disc space was tight, if the angle was difficult, if cantilever force was applied, if there was difficulty inserting the cage, and the patient's bone quality.Possible root causes from the risk table for the cage fracturing during removal include excessive cantilever force, excessive axial force, difficulty removing the implant and/or inserter and/or lack of visual feedback.
Event or Problem Description
It was reported that after intra-operative placement of a tritanium pl cage, the surgeon decided to change the cage size.During removal of the cage with the inserter, the cage fractured and part of it remained inside the patient while the other part came out.The fractured cage was left in the patient and the intervertebral space was packed with autologous bone to prevent it from moving.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.

• Brand Name: 9MM X 6DEG X 9MM X 23MM
• 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: 10155564
• Report Number: 3004024955-2020-00009
• Device Sequence Number: 2420815
• Product Code: MAX
• UDI-Device Identifier: 07613327117318
• UDI-Public: 07613327117318
• Combination Product (Y/N): N
• PMA/510(K) Number: K181014
• 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): 08/27/2020

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: 48950096
• Device Catalogue Number: 48950096
• Device Lot Number: EHT7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1