MAUDE Adverse Event Report: STRYKER SPINE-US 10X23X12DEG-9; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48950102
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cage was migrated from original position post-operatively.The patient was in pain and underwent revision surgery.
Additional Manufacturer Narrative
Method: labelling review and risk assessment.Visual, dimensional, functional and materials analysis could not be performed as device remains implanted in patient.Manufacturing record review and complaint history review could not be performed because lot number was not provided.No information was provided regarding the last step of disc space sizing (the fit and feel of the trial in the disc space).X-ray images, operation notes, and information related to the patient¿s status and postoperative activity were requested but have not been made available.With the available information, the root cause of the reported event cannot be determined.
Event or Problem Description
It was reported that the cage was migrated from original position post-operatively.The patient was in pain and underwent revision surgery.

• Brand Name: 10X23X12DEG-9
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8366937
• Report Number: 3004024955-2019-00007
• Device Sequence Number: 11220775
• Product Code: MAX
• UDI-Device Identifier: 07613327295023
• UDI-Public: 07613327295023
• Combination Product (Y/N): N
• PMA/510(K) Number: K162262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: Health Professional
• Device Catalogue Number: 48950102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1