MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 0DEG X 11MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48953090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the cage broke during insertion and positioning of cage.The correct inserter (size 11) was allegedly threaded onto cage and implanted.There was no reported delays or adverse event occurred during surgery.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The customer reported event was confirmed via visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The most likely cause of the reported event was determined to be user error-pull back the cage which is not supposed to be done.
Event or Problem Description
It was reported that; the cage broke during insertion and positioning of cage.The correct inserter (size 11) was allegedly threaded onto cage and implanted.There was no reported delays or adverse event occurred during surgery.

• Brand Name: 9MM X 0DEG 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: 6344242
• Report Number: 3004024955-2017-00011
• Device Sequence Number: 1577541
• Product Code: MAX
• UDI-Device Identifier: 07613327117851
• UDI-Public: (01)07613327117851
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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: 48953090
• Device Lot Number: AHJK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR