MAUDE Adverse Event Report: XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482319570
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head of a xia 3 polyaxial screw broke off during set screw placement intra-operatively.The procedure was completed successfully with a 15 minute surgical delay.No adverse consequences nor medical intervention were reported.
Additional Manufacturer Narrative
Updated b5 to reflect tulip disengagement instead of "broke".Visual inspection confirmed that the tulip head is disengaged from screw shank.The locking ring on tulip head is deformed, and the shank bulb head has a deep deformation on one side of the bulb head.Device history records and complaint history records were reviewed for the corresponding lot number, and no relevant issues or complaints were identified.Complaint history records was also reviewed for the corresponding catalog number, and no similar complaints were identified.From the xia surgical technique guide: the blocker is assembled onto the universal tightener for insertion.The universal tightener is available in three different options; standard, short, and double-ended.Note: the xia 3 universal tightener is not to be used for final tightening.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.Note: do not exceed 12nm during final tightening.The anti-torque key must be used for final tightening.The amount of deformation observed on the returned device indicates excessive torque over 12nm was applied during set screw insertion.Location of shank bulb deformation and locking ring deformation indicates screw being angulated which may have increased the stress on the tulip head.The most likely cause of the reported event was determined to be excessive force and/or torque applied during initial tightening.
Event or Problem Description
It was reported that the head of a xia 3 polyaxial screw disengaged during set screw placement intra-operatively.The procedure was completed successfully with a 15 minute surgical delay.No adverse consequences nor medical intervention were reported.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 70MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• MDR Report Key: 12176019
• Report Number: 3005525032-2021-00033
• Device Sequence Number: 11168372
• Product Code: NKB
• UDI-Device Identifier: 04546540598738
• UDI-Public: 04546540598738
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142381
• 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): 11/01/2021

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: Health Professional
• Device Model Number: 482319570
• Device Catalogue Number: 482319570
• Device Lot Number: B67766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 10/03/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1