MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48232601
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the rod was cut.While bending the vitallium rod with the french bender, the product broke in half on the back table about 2 inches in.During surgery while putting the rod in the screw, the head fell off of the screw.The screw was already in the patient.All broken fragments retrieved.
Event or Problem Description
It was reported that; the rod was cut.While bending the vitallium rod with the french bender the product broke in half on the back table about 2 inches in.During surgery while putting the rod in the screw the head fell off of the screw.The screw was already in the patient.All broken fragments retrieved.

• Brand Name: XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6498753
• Report Number: 3005525032-2017-00049
• Device Sequence Number: 495213
• Product Code: KWP
• UDI-Device Identifier: 04546540608642
• UDI-Public: (01)04546540608642
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• 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): 09/11/2017

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 Model Number: 48232601
• Device Catalogue Number: 48232601
• Device Lot Number: J4P
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 159