MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RADIUS VITALLIUM ROD 5.5 X 600 MM W/HEX; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	486613602
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery, the rod was cut on the back table with top cutter.When the rod was bent on the mayo with french bender, it snapped in half.Another rod was used to successfully complete the procedure.
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 rod was confirmed to have fractured at the laser marking dot.The most likely cause of the customer reported event is the laser marking dot, as a result of the manufacturing process.
Event or Problem Description
It was reported that; during surgery, the rod was cut on the back table with top cutter.When the rod was bent on the mayo with french bender, it snapped in half.Another rod was used to successfully complete the procedure.

• Brand Name: RADIUS VITALLIUM ROD 5.5 X 600 MM W/HEX
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6384299
• Report Number: 0009617544-2017-00075
• Device Sequence Number: 540351
• Product Code: NKB
• UDI-Device Identifier: 04546540604859
• UDI-Public: (01)04546540604859
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 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: 486613602
• Device Lot Number: LPF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• 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