MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM R T R PARALLEL CONNECTOR ANGLED - SIDE LOADING; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48235010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when the doctor tightened the connector the open connector was broken.Therefore, it was changed to a new one same size and the operation was completed.
Additional Manufacturer Narrative
Deformation of the threading along with the fracture, originating at the threaded peak in ductile overload, suggests that the blocker was misaligned and then excessive force was applied to force it to tighten down, causing the implant to fracture.The likely root cause is user error.
Event or Problem Description
It was reported that; when the doctor tightened the connector the open connector was broken.Therefore, it was changed to a new one same size and the operation was completed.

• Brand Name: XIA 3 TITANIUM R T R PARALLEL CONNECTOR ANGLED - SIDE LOADING
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 7112546
• Report Number: 3005525032-2017-00110
• Device Sequence Number: 11065233
• Product Code: MNH
• UDI-Device Identifier: 04546540602404
• UDI-Public: (01)04546540602404
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

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: 48235010
• Device Catalogue Number: 48235010
• Device Lot Number: B68339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1