MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK 11MM X 6DEG X 9MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48954116
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	10/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; lumbar cage fractured in half insitu at l5-s1.As a result, patient was brought back for revision alif surgery.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, material analysis, risk assessment.Result: the customer reported event was recognized post-op, during a patient's office visit due to experienced pain and was confirmed via x-ray image.However, it cannot be determined if the fracture was initiated intra-op or post-op.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Materials analysis has been performed on the returned cage fractured pieces.The ductile fracture morphology indicates that the fracture is likely due to overloading, not related to manufacturing defects.The root cause of the reported cage fracture cannot be determined conclusively due to the lack of information including: pre-op x-rays and mri; immediate post-op x-rays; follow-up x-rays; pre-op history and physical report of the patient and operation notes.
Event or Problem Description
It was reported that; lumbar cage fractured in half insitu at l5-s1.As a result, patient was brought back for revision alif surgery.

• Brand Name: 11MM X 6DEG X 9MM X 28MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA
• MDR Report Key: 7049713
• Report Number: 3004024955-2017-00039
• Device Sequence Number: 1423386
• Product Code: MAX
• UDI-Device Identifier: 07613327117981
• UDI-Public: (01)07613327117981
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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?: Yes
• Operator of Device: No Information
• Device Model Number: 48954116
• Device Catalogue Number: 48954116
• Device Lot Number: AHL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention