MAUDE Adverse Event Report: STRYKER SPINE-US 7MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48950076
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a tritanium pl cage fractured approximately 3 months post-operatively.No adverse consequences were reported.Revision surgery has not been performed nor scheduled at this time.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A company representative reported that a titanium pl cage fractured approximately 3 months post-operatively.No adverse consequences were reported.Revision surgery has not been performed nor scheduled at this time.

• Brand Name: 7MM 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 19741998
• Report Number: 3004024955-2024-00009
• Device Sequence Number: 14362739
• Product Code: MAX
• UDI-Device Identifier: 07613327117288
• UDI-Public: (01)07613327117288(11)210610(10)T9EK
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: 48950076
• Device Lot Number: T9EK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2021
• 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 Sex: Unknown