MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48955106
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon did not like the trajectory of the tritanium pl cage and that while repositioning the implant into the patients' disc space, the implant broke resulting in a 3 minute delay to obtain another implant.No adverse consequences to the patient.And surgery was completed successfully.
Additional Manufacturer Narrative
Visual, dimensional, functional, and material analysis could not be performed as the device was not returned.Device history records were reviewed and no relevant manufacturing issues were identified as all units met stryker specifications.Complaint history review records were reviewed and 1 similar report was identified.Per surgical technique: a surgical revision may be indicated for many reasons including new or unresolved pain or neurological symptoms, changes in implant positioning, non-union or incomplete fusion, etc.If necessary, the tritanium pl cage can be removed with the use of the avs pl inserter and a mallet or slap hammer.The surgeon must use his/her professional judgment to determine the appropriate revision strategy taking into consideration the patient¿s health, the nature of the problem and/or implant failure, the patient¿s bone quality and the surgeon¿s expertise with other spinal treatments and instrumentation.Revision guidelines state 'soft tissue around the surface of the implant should be removed; an osteotome or rongeurs can be used to remove any bony tissue secured to the implant; the avs pl inserter is reattached to the implant to remove it from the surgical site; a mallet or slap hammer can be used to aid in withdrawal of the implant.Alternatively, if the avs pl inserter cannot be reattached to the implant, forceps or other manual surgical instruments may be used to grasp and extract the implant.' as the device was not returned, a definite root cause cannot be determined.Possible root causes 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.A capa has been initiated with the goal of investigating the cause(s) and contributing factor(s) of this product issue and to implement the necessary actions to enhance the cage strength as part of continuous improvement.
Event or Problem Description
It was reported that the surgeon did not like the trajectory of the tritanium pl cage and that while repositioning the implant into the patients' disc space, the implant broke resulting in a 3 minute delay to obtain another implant.No adverse consequences to the patient.And surgery was completed successfully.

• Brand Name: 10MM 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: 8826444
• Report Number: 3004024955-2019-00031
• Device Sequence Number: 2390304
• Product Code: MAX
• UDI-Device Identifier: 07613327118087
• UDI-Public: 07613327118087
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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 Catalogue Number: 48955106
• Device Lot Number: D7N7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1