MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 6DEG X 11MM X 23MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48951106
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during plif surgery using cage, one of the cages protruded to the anterior side upon final impaction.Since the protruded cage was unable to be removed from posterior side, removal surgery is scheduled in the near future.
Additional Manufacturer Narrative
Device history review, complaint history review, risk assessment; the customer reported event was confirmed via email correspondence.Product is not returned, as is still implanted therefore product evaluation could not be performed.X-ray images were not provided due to hospital policy.No revision surgery has been performed and no adverse consequences has been reported.Manufacturing history review was performed and no relevant manufacturing issues were identified.Based on the information and the risk file review, it is likely that the reported protrusion of the cage is due to excessive impaction force applied during the insertion of the cage into slightly short disc space.
Event or Problem Description
It was reported that; during plif surgery using cage, one of the cages protruded to the anterior side upon final impaction.Since the protruded cage was unable to be removed from posteior side, removal surgery is scheduled in the near future.

• Brand Name: 10MM X 6DEG X 11MM X 23MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7160566
• Report Number: 3004024955-2018-00001
• Device Sequence Number: 19279169
• Product Code: MAX
• UDI-Device Identifier: 07613327117585
• UDI-Public: (01)07613327117585
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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?: No
• Operator of Device: No Information
• Device Model Number: 48951106
• Device Catalogue Number: 48951106
• Device Lot Number: D0H5
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention