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

Model 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	04/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that primary surgery was performed on (b)(6) 2013 and devices were implanted from t4 to iliac.Post operatively it was discovered that the rod broke at the head side of t12.Revision surgery took place on (b)(6) 2018.The screw was deployed from t7 to t11 and the rod was cut at the caudal side of the of the t12 and the screw of the t12 was removed.Finally, it was extended with connector and the operation was finished.
Event or Problem Description
It was reported that primary surgery was performed on (b)(6), 2013 and devices were implanted from t4 to iliac.Post operatively it was discovered that the rod broke at the head side of t12.Revision surgery took place on (b)(6), 2018.The screw was deployed from t7 to t11 and the rod was cut at the caudal side of the of the t12 and the screw of the t12 was removed.Finally, it was extended with connector and the operation was finished.

• 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: 7493406
• Report Number: 0009617544-2018-00107
• Device Sequence Number: 13781664
• Product Code: NKB
• UDI-Device Identifier: 04546540560582
• UDI-Public: (01)04546540560582
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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 Model Number: 48232600
• Device Catalogue Number: 48232600
• Device Lot Number: CBK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 08/13/2018
• 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