MAUDE Adverse Event Report: STRYKER SPINE-US 8MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48955086
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the surgeon phoned to say his patient had suffered a fall 2 weeks postoperatively and as a consequence has leg pain.The surgeon reported that on x-ray the cages appears to have retro pulsed out of the disc space.The x-rays have not yet been viewed by the rep.
Additional Manufacturer Narrative
Investigation concluded."no complaint reported with this product, it's confirmed to be a concomitant product.".
Event or Problem Description
It was reported that; the surgeon phoned to say his patient had suffered a fall 2 weeks postoperatively and as a consequence has leg pain.The surgeon reported that on x-ray the cages appears to have retro pulsed out of the disc space.The x-rays have not yet been viewed by the rep.

• Brand Name: 8MM 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: 6085162
• Report Number: 3004024955-2016-00100
• Device Sequence Number: 363804
• Product Code: MAX
• UDI-Device Identifier: 07613327118063
• UDI-Public: (01)07613327118063
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2017

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 Catalogue Number: 48955086
• Device Lot Number: A96D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1