MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK 10MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48955106
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cage fractured during insertion.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; the device was inspected and it's confirmed that the cage was fractured.No relevant manufacturing issues were identified as all units met specifications.The most likely cause of the reported event was determined to be user related: twisting and torque was used , which was not recommended in the surgical techniques.
Event or Problem Description
It was reported that the cage fractured during insertion.

• Brand Name: 10MM X 6DEG X 11MM X 28MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• MDR Report Key: 6478126
• Report Number: 3004024955-2017-00017
• Device Sequence Number: 16465985
• Product Code: MAX
• UDI-Device Identifier: 07613327118087
• UDI-Public: (01)07613327118087
• Combination Product (Y/N): N
• 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): 06/28/2017

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: 48955106
• Device Lot Number: AAET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1