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

Catalog Number	48955116
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Vertebral Fracture (4520); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tritanium posterior lumbar cage fractured during insertion.The procedure was completed successfully with a 10 minute surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Device remains implanted.
Additional Manufacturer Narrative
Additional data: b5.H6 codes have been updated to reflect conclusion of the investigation.
Event or Problem Description
It was reported that a tritanium posterior lumbar cage fractured during insertion.The procedure was completed with a 10 minute surgical delay and it was further reported that the patient sustained a vertebral fracture.No medical intervention was required.

• Brand Name: 11MM 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
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 19144567
• Report Number: 3004024955-2024-00007
• Device Sequence Number: 18029392
• Product Code: MAX
• UDI-Device Identifier: 07613327118094
• UDI-Public: 07613327118094
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 48955116
• Device Lot Number: E6NL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2020
• 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 Sex: Unknown