MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE.

Model Number	48955106
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the cage deformed upon insertion.The cage remains implanted in the patient.No adverse consequences to the patient is reported.
Event or Problem Description
It is reported that the cage deformed upon insertion.The cage remains implanted in the patient.No adverse consequences to the patient is reported.
Additional Manufacturer Narrative
Method: x-rays, device history review, complaint history review, risk assessment; result: the reported event was confirmed via x-ray image and correspondence.The cage was not available for evaluation because it is still implanted.The event resulted in neither surgical delay nor other adverse consequences manufacturing records were reviewed for the corresponding lot and no relevant issues were identified conclusion: the most likely cause of the reported event was determined to be user related - the cage hit a screw that had penetrated the endplate and was protruding into the disc space.
Additional Manufacturer Narrative
Method: x-rays, device history review, complaint history review, risk assessment; result: the reported event was confirmed via x-ray image and correspondence.The cage was not available for evaluation because it is still implanted.The event resulted in neither surgical delay nor other adverse consequences manufacturing records were reviewed for the corresponding lot and no relevant issues were identified conclusion: the most likely cause of the reported event was determined to be user related - the cage hit a screw that had penetrated the endplate and was protruding into the disc space.
Event or Problem Description
It is reported that the cage deformed upon insertion.The cage remains implanted in the patient.No adverse consequences to the patient is reported.

• Brand Name: 10MM X 6DEG 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: 7322754
• Report Number: 3004024955-2018-00009
• Device Sequence Number: 151984
• Product Code: MAX
• UDI-Device Identifier: 07613327118087
• UDI-Public: (01)07613327118087
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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: No Information
• Device Model Number: 48955106
• Device Catalogue Number: 48955106
• Device Lot Number: D1D4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR