MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482318540
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tulip of a xia 3 titanium polyaxial screw disengaged during implantation.The shaft of the screw remains in the patient's bone and the procedure was completed following a five-minute surgical delay.
Additional Manufacturer Narrative
The returned tulip was visually inspected.The locking ring is deformed and fractured.The 4th thread on one side of the tulip is fractured.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.A review of complaint history associated with the subject catalog and lot number was performed, and no adverse trends were observed.It was further reported via follow up communication that the surgeon choose to replace all the screws and the s1 level was skipped as the shank remained in the bone.Patient had good bone quality.It was also reported that the tulip was not over angulated and that the normal xia anti torque and audible torque wrench were used.The degree of the locking ring fracture on the returned device indicates that the tulip was most likely over angulated during final tightening.The location of the thread fracture observed indicates that the final tightener was most likely cantilevered during final tightening.Minor damage is observed on the 3rd thread, however none observed on the first two threads.This indicates cantilevering of the tightener applied the pressure to the bottom of the blocker on the side that the device was cantilevered towards.The most likely cause of the reported event was determined to be due to cantilevering of the final tightener while final tightening.It is likely that the tulip was highly angulated with respect to the screw shank, which likely amplified the stress on the locking ring to cause it to fracture.
Event or Problem Description
It was reported that the tulip of a xia 3 titanium polyaxial screw disengaged during implantation.The shaft of the screw remains in the patient's bone and the procedure was completed following a five-minute surgical delay.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; SZ 2300
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14847976
• Report Number: 3005525032-2022-00015
• Device Sequence Number: 19993521
• Product Code: NKB
• UDI-Device Identifier: 04546540598585
• UDI-Public: 04546540598585
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: 482318540
• Device Catalogue Number: 482318540
• Device Lot Number: B68492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2016
• 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
• Patient Age: 45 YR
• Patient Sex: Unknown
• Patient Weight: 100 KG