MAUDE Adverse Event Report: STRYKER SPINE-US 9X23X12DEG-9; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48950092
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that two tritanium pl cages migrated post-operatively.The patient is experiencing pain in their left leg.Revision surgery will be needed.This report captures the second of the two cages.
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 for this lot, and no relevant manufacturing issues or similar complaints were identified.From the tritanium pl 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.The device was not returned, xrays were not provided, and no additional information about the surgery or the patient was provided.At this time, a root cause cannot be determined.Possible causes include: inadequate initial fixation; latent infection; premature loading of the device or trauma; improper cage size; patient bone quality; patient activity level; inadequate preparation of the disc space.
Event or Problem Description
It was reported that two tritanium pl cages migrated post-operatively.The patient is experiencing pain in their left leg.Revision surgery will be needed.This report captures the second of the two cages.Revision surgery has occurred.

• Brand Name: 9X23X12DEG-9
• 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: 11702753
• Report Number: 3004024955-2021-00005
• Device Sequence Number: 19703323
• Product Code: MAX
• UDI-Device Identifier: 07613327295009
• UDI-Public: 07613327295009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: 06/20/2024
• Device Model Number: 48950092
• Device Catalogue Number: 48950092
• Device Lot Number: K3EA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 07/27/2021
• 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