MAUDE Adverse Event Report: STRYKER SPINE-US XIA II VITALIUM ROD 6.0 MM X 600 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03822601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a xia construct on (b)(6) 2017.On (b)(6) 2018, it was reported that the tulip of a xia 3 polyaxial screw disengaged and the right side xia ii rod fractured after the patient experienced a fall.On 12 november 2021, it was reported that the patient had been revised on (b)(6) 2021 to address the previously reported disengaged screw and fractured rod, as well as a second rod fracture (on the left side).During revision surgery, a xia 3 polyaxial screw was noted to be loose and two xia 3 multiaxial crosslinks were removed.Evaluation of the returned devices identified that both crosslinks were fractured.This record captures the second fractured xia ii vitalium rod.
Additional Manufacturer Narrative
A visual inspection was performed which confirmed rod fracture.Wear marks observed on anterior and posterior side of rod indicate blockers may not have been properly tightened.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.It was reported that the patient experienced a fall in (b)(6) 2018, after which, x-ray revealed the right rod to be fractured.Left rod fracture cannot be observed in the x-ray, however, returned rod was confirmed to be fractured in a similar location to right rod.According to x-rays, the right rod fractured just superior to right l5 screw head.It was also reported that the left iliac screw tulip head was previously 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.The xia surgical technique and device ifu were reviewed: ¿these implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.The surgeon must warn the patient of the surgical risks and that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advice the patient that resultant forces can cause failure of the device.¿ the most likely cause of the reported event was determined to be due to patient fall.
Event or Problem Description
The patient was implanted with a xia construct on (b)(6) 2017.On (b)(6) 2018, it was reported that the tulip of a xia 3 polyaxial screw disengaged and the right side xia ii rod fractured after the patient experienced a fall.On (b)(6) 2021, it was reported that the patient had been revised on (b)(6) 2021 to address the previously reported disengaged screw and fractured rod, as well as a second rod fracture (on the left side).During revision surgery, a xia 3 polyaxial screw was noted to be loose and two xia 3 multiaxial crosslinks were removed.Evaluation of the returned devices identified that both crosslinks were fractured.This record captures the second fractured xia ii vitalium rod.

• Brand Name: XIA II VITALIUM ROD 6.0 MM X 600 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: 12977777
• Report Number: 0009617544-2021-00231
• Device Sequence Number: 17212893
• Product Code: NKB
• UDI-Device Identifier: 04546540539656
• UDI-Public: 04546540539656
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• 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: 03822601
• Device Catalogue Number: 03822601
• 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): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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