MAUDE Adverse Event Report: STRYKER SPINE-US 11MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48950116
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient with neurological symptoms was revised approximately 2.5 years post-operatively to address two migrated tritanium posterior lumbar cages (addressed in (b)(6)).While attempting to remove the two lumbar cages with an avs spacer inserter, both cages fractured and the inserter deformed intra-operatively.The fractured components of the cages were explanted, however the rest of the cages remained implanted.The cage surfaces were smoothed and decompression was successfully completed to alleviate the neurological symptoms.This report captures the first of two lumbar cages.
Additional Manufacturer Narrative
Additional data: d4, d9, h3, h4 corrected data: g1 h6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
It was reported that a patient with neurological symptoms was revised approximately 2.5 years post-operatively to address two migrated tritanium posterior lumbar cages (addressed in pi 3784790).While attempting to remove the two lumbar cages with an avs spacer inserter, both cages fractured and the inserter deformed intra-operatively.The fractured components of the cages were explanted, however the rest of the cages remained implanted.The cage surfaces were smoothed and decompression was successfully completed to alleviate the neurological symptoms.This report captures the first of two lumbar cages.

• Brand Name: 11MM 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 20747618
• Report Number: 3004024955-2024-00016
• Device Sequence Number: 8648919
• Product Code: MAX
• UDI-Device Identifier: 07613327117356
• UDI-Public: (01)07613327117356(11)210428(10)PP74
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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: 48950116
• Device Lot Number: PP74
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian