MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482319540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during fine adjustment of the screw head with intraoperative mono driver, the screw head broke.The screw was removed and replaced with another screw with no adverse consequences to the patient.
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence with the representative.The surgery was completed successfully with no delay.The device was discarded and lot number was not provided, so manufacturing record review could not be performed.According to the risk assessment, tulip disengagement can occur due to incorrect alignment, screw inserted incorrectly (ex.Too deep), deformed/splayed tulip head, deformed or damaged instrument, or excessive force applied.As the screw was not returned, a definite root cause cannot be determined, however it is possible one or more of the possible root causes mentioned contributed to the event.The definitive root cause can not be established.
Event or Problem Description
It was reported that during fine adjustment of the screw head with intraoperative mono driver, the screw head broke.The screw was removed and replaced with another screw with no adverse consequences to the patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7796630
• Report Number: 3005525032-2018-00050
• Device Sequence Number: 1468966
• Product Code: NKB
• UDI-Device Identifier: 04546540598677
• UDI-Public: 04546540598677
• Combination Product (Y/N): N
• PMA/510(K) Number: K083393
• 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): 10/22/2018

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 Catalogue Number: 482319540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1