MAUDE Adverse Event Report: STRYKER SPINE-US 8MM X 0DEG X 11MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48953080
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The patient had a l5-s1 fusion on (b)(6) 2017.The patient images looked normal on several follow up appointments post op and patient appeared to be doing well.On his most recent follow-up appointment, the surgeon noticed the cage was fractured in a post op x-ray.The pedicle screws appear normal and the patient is not symptomatic.
Event or Problem Description
The patient had a l5-s1 fusion on (b)(6) 17.The patient images looked normal on several follow up appointments post op and patient appeared to be doing well.On his most recent follow-up appointment, the surgeon noticed the cage was fractured in a post op x-ray.The pedicle screws appear normal and the patient is not symptomatic.
Additional Manufacturer Narrative
Method: product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed based on the review of x-ray images.The reported device was not returned, therefore, product inspection could not be performed.Manufacturing records were reviewed for both lots and no relevant issues were identified.Conclusion: it cannot be determined when the cage fracture was initiated.The root cause of the reported cage fracture cannot be determined due to insufficient information and product not returned for analysis.Remedial action: stryker has decided to take a field action (3004024955-11/14/18-001-c).Specifically, stryker executed a correction by updating the surgical technique guide to warn end users against misuses which include extreme surgical techniques that fall outside the approved instructions for use.H3 other text : device not returned.

• Brand Name: 8MM X 0DEG X 11MM X 28MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7474270
• Report Number: 3004024955-2018-00021
• Device Sequence Number: 194233
• Product Code: MAX
• UDI-Device Identifier: 07613327117844
• UDI-Public: (01)07613327117844
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 48953080
• Device Catalogue Number: 48953080
• Device Lot Number: AD85
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1