MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48232600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was implanted from t8 to iliac and fixed from t10 to l3/4 with 4 rods on (b)(6) 2014.On (b)(6) 2018 it was confirmed both side rods were broken.Right broken part was l5/s and left broken part was secru / iliac.On (b)(6) 2018 rods were removed and revised.
Additional Manufacturer Narrative
Method: visual analysis, material analysis, device history review, complaint history review, risk assessment.Result: the rod was returned in 2 pieces with the hex end fractured from the rest of the rod.The device was sent for material analysis.The elemental constituent was consistent with the material listed on the print.Material analysis of the device confirmed fatigue fracture at the contact point with the polyaxial screw.No material or manufacturing defects were found.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely root cause is fatigue fracture of the rod due to length of implantation.As non fusion, patient activity level, and patient fall are unknown, these can also be contributing factors to the rod fracture.
Event or Problem Description
It was reported that the patient was implanted from t8 to iliac and fixed from t10 to l3/4 with 4 rods on (b)(6) 2014.On (b)(6) 2018 it was confirmed both side rods were broken.Right broken part was l5/s and left broken part was secru / iliac.On (b)(6) 2018 rods were removed and revised.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7537708
• Report Number: 0009617544-2018-00111
• Device Sequence Number: 19126726
• Product Code: NKB
• UDI-Device Identifier: 04546540560582
• UDI-Public: 04546540560582
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48232600
• Device Lot Number: GC6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 57