MAUDE Adverse Event Report: STRYKER SPINE-US XIA ROD DIA. 6 X 480; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03802480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced pain and imaging revealed a fractured xia lp polyaxial screw, a fractured xia rod, and a xia 3 titanium polyaxial screw with "head pull out." the patient underwent revision surgery.The body of the xia 3 titanium polyaxial screw was not able to be removed and remains implanted in the patient's illium.This report captures the fractured xia ii rod.
Additional Manufacturer Narrative
D6b, date of explant, was corrected from "(b)(6) 2021" to "(b)(6) 2021 visual, dimensional, material and functional analysis could not be performed as the device was not returned manufacturing 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.Review of x-ray reveals the following.Rod fracture is observed between l4/l5 screw on the patients right side.The iliac screw on the left side attached to the main rod fractured at the head of the screw.This screw shank was unable to be removed.The tulip of the adjacent iliac screw, which is attached by an extender to l1 space, appears to have disengaged from the screw shank.This shank was able to be removed and replaced with a new screw.Additionally, the right l2 screw was removed to make space for a rod extender connecting a new iliac screw on the right.A new iliac screw was added between the 2 existing iliac screws on the left side, and connected to the main rod.The xia ii lp polyaxial screw system device ifu were reviewed: these implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.The most likely cause of the reported event was determined to be due to the age of device implantation.After one year, fusion is expected and was achieved, therefore the devices served their intended purpose.Due to rod and screw fractures/disengagement occurring on opposite sides, but similar levels, it is potential that a fall/external event may have contributed to the event.However, this cannot be confirmed as it was reported that no external trauma was experienced.
Event or Problem Description
It was reported that a patient experienced pain and imaging revealed a fractured xia lp polyaxial screw, a fractured xia rod, and a xia 3 titanium polyaxial screw with "head pull out." the patient underwent revision surgery.The body of the xia 3 titanium polyaxial screw was not able to be removed and remains implanted in the patient's illium.This report captures the fractured xia ii rod.
Additional Manufacturer Narrative
Coding has been updated to reflect device evaluation and investigation conclusion.
Event or Problem Description
It was reported that a patient experienced pain and imaging revealed a fractured xia ii lp polyaxial screw, a fractured xia ii rod, and a xia 3 titanium polyaxial screw with "head pull out." the patient underwent revision surgery.The body of the xia 3 titanium polyaxial screw was not able to be removed and remains implanted in the patient's ilium.This report captures the xia ii rod.

• Brand Name: XIA ROD DIA. 6 X 480
• 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: 12407887
• Report Number: 3005525032-2021-00036
• Device Sequence Number: 17440720
• Product Code: NKB
• UDI-Device Identifier: 04546540147905
• UDI-Public: 04546540147905
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2022

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: 03802480
• Device Catalogue Number: 03802480
• Device Lot Number: 7UZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 11/24/2021; 10/07/2022
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 12/17/2021; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2019
• 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 Age: 11 YR
• Patient Sex: Male