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

Catalog Number	48953090
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	03/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; upon implanting an interbody device the cage became twisted.The surgeon noticed it, removed the implant and a new cage was used successfully.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The returned cage was found not only twisted but also fractured.The most likely cause of the reported event was determined to be torsional overload when the surgeon tried to adjust the angle; misaligned force applied on the cage.
Event or Problem Description
It was reported that; upon implanting a interbody device the cage became twisted.The surgeon noticed it, removed the implant and a new cage was used successfully.

• 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: 6460971
• Report Number: 3004024955-2017-00016
• Device Sequence Number: 479249
• Product Code: MAX
• UDI-Device Identifier: 07613327117851
• UDI-Public: (01)07613327117851
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 06/21/2017

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: A9T6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1