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

Model Number	482316545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Disposed by customer.
Event or Problem Description
It was reported that a xia 3 polyaxial screw fractured post-operatively, due to construct instability.Revision surgery has been performed due to this issue.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The surgeon suggested that the event could have occurred due to instability due to lack of fusion.The patient was reported to be overweight with diabetes.Operative notes from initial/ revision surgery and x-rays are not available.It is unknown if there were any complications during the initial surgery, how the screw holes were prepared, and if the device was implanted at a difficult angle.The device was scrapped by customer so an evaluation could not be performed.The xia 3 surgical technique was reviewed, and the following relevant information was identified: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.If a nonunion develops or if the implants loosen, bend or break, the device(s) should be revised or removed immediately before serious injury occurs.An overweight or obese patient can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself.It is likely that the device fractured due to patient non-fusion.However without the device and supporting operative notes/ x-rays, an exact cause cannot be determined.Other potential causes include: poor bone quality of patient, high activity level/ external trauma/ fall, poor initial construct stability, etc.
Event or Problem Description
It was reported that a xia 3 polyaxial screw fractured post-operatively, due to construct instability.Revision surgery has been performed due to this issue.

• 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-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12790905
• Report Number: 0009617544-2021-00219
• Device Sequence Number: 17112317
• Product Code: NKB
• UDI-Device Identifier: 04546540562241
• UDI-Public: 04546540562241
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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: 482316545
• Device Catalogue Number: 482316545
• Device Lot Number: 205517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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