MAUDE Adverse Event Report: STRYKER SPINE-US 11MM X 6DEG X 9MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	48954116
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the surgeon did a couple taps during insertion of the cage and tried to turn and steer the cage.The nose of the cage was in the disc space was under load and the rest of the cage was not in.When rotating and steering the cage, it gave way behind the nose and it broke into multiple fragments that did not fall in the patient cavity.All fragments were retrieved.Used 1mm smaller sized cage to complete the procedure (10mm) procedure was completed successfully.No adverse consequences of the patient reported.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual, dimensional and functional analysis could not be performed as the explanted cage was discarded.Conclusion:.The most likely cause was determined to be related to not opening up enough disc space prior to the cage insertion for the patient's tight disc space.
Event or Problem Description
It is reported that the surgeon did a couple taps during insertion of the cage and tried to turn and steer the cage.The nose of the cage was in the disc space was under load and the rest of the cage was not in.When rotating and steering the cage, it gave way behind the nose and it broke into multiple fragments that did not fall in the patient cavity.All fragments were retrieved.Used 1 mm smaller sized cage to complete the procedure (10 mm) procedure was completed successfully.No adverse consequences of the patient reported.

• Brand Name: 11MM 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: 6322395
• Report Number: 3004024955-2017-00009
• Device Sequence Number: 13622089
• Product Code: MAX
• UDI-Device Identifier: 07613327117981
• UDI-Public: (01)07613327117981
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 04/18/2017

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: 48954116
• Device Lot Number: AAYY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 04/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1