MAUDE Adverse Event Report: STRYKER SPINE-US 7MM X 6DEG X 9MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48954076
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital retained implant.
Event or Problem Description
It was reported that following a fall approximately 1 month post-operatively, a patient's tritanium pl cage at l4-l5 migrated from the disk space.Fusion was not achieved.Revision surgery was performed where the cage was explanted.
Event or Problem Description
It was reported that following a fall approximately 1 month post-operatively, a patient's tritanium pl cage at l4-l5 migrated from the disk space.Fusion was not achieved.Revision surgery was performed where the cage was explanted.
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, no relevant manufacturing issues or similar complaints were identified.Per additional correspondence, patient fell led to the cage migration.Fusion was not achieved.Patient had a tight disc space.Everest screws were installed as a supplemental fixation system.Patient' bone quality was reported to be normal.Patient's bmi is unknown.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.It is likely that the device migrated due to patient fall.Other potential causes include: inadequate initial fixation, latent infection, premature loading of the device or trauma, improper cage size, and inadequate preparation of the disc space can contribute to the event.

• Brand Name: 7MM X 6DEG X 9MM X 28MM
• Common Device Name: 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 ; EI NA
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12094825
• Report Number: 3004024955-2021-00019
• Device Sequence Number: 19685900
• Product Code: MAX
• UDI-Device Identifier: 07613327117943
• UDI-Public: 07613327117943
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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 Model Number: 48954076
• Device Catalogue Number: 48954076
• Device Lot Number: ANM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown