MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48950106
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return status of the device is unknown.
Event or Problem Description
A physician reported that approximately one month after a l2/3/4/5 plif implantation, the patient underwent revision surgery to address a backed-out tritanium pl cage.Revision surgery was performed to remove the cage and extend the fixation range as the bone had collapsed.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed, and no relevant manufacturing or similar complaints were identified.Per surgical technique: early loosening may result from inadequate initial fixation, latent infection, premature loading of the device or trauma.Late loosening may result from trauma, infection, biological complications or mechanical problems, with the subsequent possibility of bone erosion, or pain.There is not enough information to determine a root cause.The patient's bone quality is unknown and it is unknown if the patient had any sort of medical issues that could have caused the bone itself to collapse.It cannot be determined with the information provided if the tritanium pl cage contributed to the bone collapse.The cage most likely migrated due to the patient's bone collapse, however the cause for the bone collapse is unknown at this time.
Event or Problem Description
A physician reported that approximately one month after a l2/3/4/5 plif implantation, the patient underwent revision surgery to address a backed-out tritanium pl cage.Revision surgery was performed to remove the cage and extend the fixation range as the bone had collapsed.

• Brand Name: 10MM 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: 9252407
• Report Number: 3004024955-2019-00045
• Device Sequence Number: 19346634
• Product Code: MAX
• UDI-Device Identifier: 07613327117417
• UDI-Public: 07613327117417
• Combination Product (Y/N): N
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2022
• Device Catalogue Number: 48950106
• Device Lot Number: DD0D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR