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

Model Number	48950096
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Peritoneal Laceration(s) (2003)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: we were provided two possible lot number for the cage, either g2x2 or gneu and we are pursuing clarification from the field.Clarification will be provided in a follow up supplemental report if we get it.H3 other text : device remains implanted.
Event or Problem Description
It was reported that, during implantation of a tritanium posterior lumbar cage, the surgeon penetrated the anterior longitudinal ligament.The cage was left in place.The surgeon has planned additional imaging and angiography.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was reported that, during implantation of a tritanium posterior lumbar cage, the surgeon penetrated the anterior longitudinal ligament.The cage was left in place.The surgeon has planned additional imaging and angiography.

• Brand Name: 9MM 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: 17097521
• Report Number: 3004024955-2023-00003
• Device Sequence Number: 1868647
• Product Code: MAX
• UDI-Device Identifier: 07613327117318
• UDI-Public: 07613327117318
• 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: 2023
• 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): 10/11/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 48950096
• Device Catalogue Number: 48950096
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 10/11/2023
• 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: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian