MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X11MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE.

Model Number	48955096
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during tlif procedure the cage broke apart into pieces while inserting.
Event or Problem Description
It was reported that during tlif procedure the cage broke apart into pieces while inserting.

• Brand Name: 9MM X 6DEG X11MM X 28MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6638805
• Report Number: 3004024955-2017-00024
• Device Sequence Number: 16414541
• Product Code: MAX
• UDI-Device Identifier: 07613327118070
• UDI-Public: (01)07613327118070
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

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: 48955096
• Device Catalogue Number: 48955096
• Device Lot Number: AHE7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 102