MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.

Model Number	482316545
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had been fused from l3-s1.As they were taking the instrumentation out of patient, screw was already broken.No harm was done to the patient and left the bottom half of the screw in the patient.
Additional Manufacturer Narrative
No manufacturing defects were found.Visual inspection showed the screw was returned with the bottom portion of the threaded body fractured off and missing from the rest of the screw.The definitive root cause of the event cannot be determined with the given information.
Event or Problem Description
It was reported that the patient had been fused from l3-s1.As they were taking the instrumentation out of patient, screw was already broken.No harm was done to the patient and left the bottom half of the screw in the patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM
• 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: 6876218
• Report Number: 3005525032-2017-00092
• Device Sequence Number: 1460710
• Product Code: MNH
• UDI-Device Identifier: 04546540562241
• UDI-Public: (01)04546540562241
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 12/14/2017

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: 482316545
• Device Catalogue Number: 482316545
• Device Lot Number: B50795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1