MAUDE Adverse Event Report: STRYKER SPINE-US POSTERIOR LUMBAR CAGE 9MM X 28MM X6DEG - 11MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48955096
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that a tritanium pl cage fractured approximately two-years post-operatively.Revision surgery has not been scheduled.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, and no adverse trends were observed.It was reported that a tritanium pl cage at l4-l5 fractured post-operatively.Initial surgery was performed on (b)(6) 2020.Revision surgery has not been scheduled and it is unknown if the patient fused.Due to lack of information and device not returned, an exact cause of the reported event could not be determined.Potential causes include: patient non-fusion/ poor bone quality of patient/ transit load on the cage over time/ excess post-op activity by patient/ patient fall or external trauma/ extreme surgical techniques outside of the approved ifu used during insertion that result in a cracked cage being implanted, but not identified at the time of implantation, etc.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.
Event or Problem Description
It was reported that a tritanium pl cage fractured approximately two-years post-operatively.Revision surgery has not been scheduled.

• Brand Name: POSTERIOR LUMBAR CAGE 9MM X 28MM X6DEG - 11MM
• 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: 13902438
• Report Number: 3004024955-2022-00003
• Device Sequence Number: 4470208
• Product Code: MAX
• UDI-Device Identifier: 07613327118070
• UDI-Public: 07613327118070
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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 Model Number: 48955096
• Device Catalogue Number: 48955096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 06/23/2022
• 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
• Patient Sex: Male