MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 8.5 X 70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	4823718570
Health Effect - Clinical Codes	Fall (1848); Injury (2348); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device still in the patient.
Event or Problem Description
It was reported that the screw head has detached intra op, the detached screw was left in the patient with no adverse consequences to the patient.Upon 15 months ((b)(6) 2017) follow up x-ray review, the complete screw head detachment was confirmed.Further, the patient fell in (b)(6) 2018, causing screw head and shaft to diverge.
Additional Manufacturer Narrative
Nc/capa history review, labelling review, risk assessment the reported event was confirmed via correspondence with sales rep.No lot # was provided, so a manufacturing record review and complaint history review could not be performed.Product was not returned so an evaluation was not possible.Nc/capa history review revealed no relevant nc/capa.Due to lack of information and no product return, root cause of the reported event could not be determined conclusively.Potential causes include but not limited to: - excessive torque applied to final tighten blocker resulting in unstable construct - application of excessive force - anti-torque key not used - universal tightener used to final tighten - force from rod pushes blocker out of tulip (insufficient rod persuasion) - incorrect assembly of anti-torque key and torque wrench device is still remained implanted int the patient.
Event or Problem Description
It was reported that the screw head has detached intra op, the detached screw was left in the patient with no adverse consequences to the patient.Upon 15 months ((b)(6) 2017) follow up x-ray review, the complete screw head detachment was confirmed.Further, the patient fell in (b)(6) 2018, causing screw head and shaft to diverge.
Event or Problem Description
It was reported that the screw head has detached intra op, the detached screw was left in the patient with no adverse consequences to the patient.Upon 15 months ((b)(6) 2017) follow up x-ray review, the complete screw head detachment was confirmed.Further, the patient fell in (b)(6) 2018, causing screw head and shaft to diverge.Update: the patient captured in this record was revised on (b)(6)2021.This record was reopened to capture the revision procedure.The explanted xia 3 titanium polyaxial screw was returned.
Additional Manufacturer Narrative
Updated section b5 to address reason for re-open.Updated d6 to add implant and explant dates.
Additional Manufacturer Narrative
A visual inspection was performed which confirmed the tulip head to be disengaged from the screw shank.Locking ring and base of tulip head are deformed indicating over angulation of tulip and excessive torque applied.Screw shank head witness mark from rod is angled heavily to one side of the screw head, also indicating tulip head over angulation and rod potentially improperly seated in tulip.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot, and no similar complaints were identified.It was reported that the left iliac screw tulip head was noticed to be disengaged in the immediate post-op x-ray ((b)(6) 2017), but did not disengage completely from the screw until 1 week after the procedure.X-ray from (b)(6) 2017 confirms that the left iliac screw shank is completely disengaged from tulip head.It was reported that it is unknown whether the surgeon applied excessive force on the screw, at what torque was the blocker tightened to, which instruments were used, patient's bone quality and post-op activity.Immediate post-op x-ray reveals that screw tulip is highly angled with respect to the shank.Additionally, it was reported that the patient experienced a fall in (b)(6) 2018, after which, x-ray revealed the right rod to be fractured.The xia 3 surgical technique and device ifu were reviewed: ¿in the event the rod is forced down while tightening the blocker, be sure that the blocker is fully engaged into the screw head.This will help resist the high reactive forces generated by the final tightening maneuvers.¿ caution: ¿extra caution is advised in the following cases: the rod is not horizontally placed into the screw head.The rod is high in the screw head.An acute convex or concave bend is contoured into the rod.¿ ¿once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed.Use the anti-torque key and the torque wrench.¿ the most likely cause of the reported event was determined to be excessive angulation of tulip head and rod placement within tulip head.Additionally, excessive torque may have contributed to the event.
Event or Problem Description
It was reported that the screw head has detached intra op, the detached screw was left in the patient with no adverse consequences to the patient.Upon 15 months ((b)(6) 2017) follow up x-ray review, the complete screw head detachment was confirmed.Further, the patient fell in (b)(6) 2018, causing screw head and shaft to diverge.Update: the patient captured in this record was revised on (b)(6) 2021.This record was reopened to capture the revision procedure.The explanted xia 3 titanium polyaxial screw was returned.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 8.5 X 70MM
• 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: 8178467
• Report Number: 3005525032-2018-00079
• Device Sequence Number: 1960088
• Product Code: NKB
• UDI-Device Identifier: 07613252045847
• UDI-Public: 07613252045847
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4823718570
• Device Catalogue Number: 4823718570
• Device Lot Number: B61184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 01/31/2019; 11/12/2021; 01/17/2022
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/01/2019; 12/10/2021; 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female