MAUDE Adverse Event Report: STRYKER SPINE-US 8MM X 6DEG X 9MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48954086
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that a patient had undergone an l5/s1 surgery on (b)(6) 2017.At the three month post-operative appointment, the physician performed an x-ray and noticed a broken cage.The patient did not report any acute pain associated with the broken cage.There were two implanted cages and it is unknown which of the cages is broken.There are no reports of patient intervention or adverse health consequences due to the broken cage.
Event or Problem Description
It was reported that a patient had undergone an l5/s1 surgery on (b)(6), 2017.At the three month post-operative appointment, the physician performed an x-ray and noticed a broken cage.The patient did not report any acute pain associated with the broken cage.There were two implanted cages and it is unknown which of the cages is broken.There are no reports of patient intervention or adverse health consequences due to the broken cage.

• Brand Name: 8MM X 6DEG X 9MM X 28MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7220327
• Report Number: 3004024955-2018-00002
• Device Sequence Number: 1447884
• Product Code: MAX
• UDI-Device Identifier: 07613327117950
• UDI-Public: (01)07613327117950
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

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: 48954086
• Device Catalogue Number: 48954086
• Device Lot Number: AAA8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 01/25/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 86