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

Model Number	486613602
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision surgery for t4- iliac, the rod broke when the surgeon was bending it over the patient.The surgeon used another rod to complete the surgery.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: the customer reported event was confirmed via visual inspection.The returned rod was confirmed to have fractured at the laser marking dot.The laser marking dot can act as stress risers when placed on the tensile side of the bend.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified conclusion: the most likely cause of the customer reported event is the laser marking dot, as a result of the manufacturing process.This issue has been addressed through a corrective action preventive action (capa).The goal of the capa was to define a new laser marking program for device to meet its performance.
Event or Problem Description
It was reported that during a revision surgery for t4- iliac, the rod broke when the surgeon was bending it over the patient.The surgeon used another rod to complete the surgery.There are no reports of adverse health consequences to the patient.

• Brand Name: RADIUS VITALLIUM ROD 5.5 X 600 MM W/HEX
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7419352
• Report Number: 0009617544-2018-00079
• Device Sequence Number: 554890
• Product Code: NKB
• UDI-Device Identifier: 04546540604859
• UDI-Public: (01)04546540604859
• Combination Product (Y/N): N
• PMA/510(K) Number: K082608
• 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): 07/23/2018

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 Model Number: 486613602
• Device Catalogue Number: 486613602
• Device Lot Number: F9F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 07/23/2018
• 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
• Patient Weight: 43