MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM MULTIAXIAL CROSSLINK 53MM 73MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48236053
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	Malfunction
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 first of two xia 3 multiaxial crosslinks removed during the revision surgery.
Additional Manufacturer Narrative
A visual inspection was performed and it was found that the cross link in this record had experienced a fracture where the main arm meets the rod hook.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.Upon return of devices, it was noted that the cross link in this record had experience a fracture where the main arm meets the rod hook.Follow up revealed that the crosslinks were damaged during hardware removal.X-rays provided confirm this as there is no fracture or disengagement observed on any post-op x-rays.The reported fall the patient experience may have compromised the mechanical or material integrity of the device, however, this cannot be confirmed.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.¿ device removal: ¿standard ancillaries provided by stryker spine can be used to remove the implants.Any decision by a physician to remove the internal fixation device must take into consideration such factors as the risk to the patient of the additional surgical procedure as well as the difficulty of removal.Removal of an unloosened spinal screw may require the use of special instruments to disrupt the interface at the implant surface.This technique may require practice in the laboratory before being attempted clinically.Implant removal should be followed by adequate postoperative management to avoid fracture or re-fracture.Removal of the implant after fracture healing is recommended.Metallic implants can loosen, bend, fracture, corrode, migrate, cause pain or stress shield bone.¿ the most likely cause of the reported event was determined to be due to excessive force during removal.Age of device may have also contributed to event.Additionally, patient fall may have compromised the mechanical or material integrity of the device prior to removal.
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 first of two xia 3 multiaxial crosslinks removed during the revision surgery.

• Brand Name: XIA 3 TITANIUM MULTIAXIAL CROSSLINK 53MM 73MM
• 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: 12977803
• Report Number: 0009617544-2021-00233
• Device Sequence Number: 4291740
• Product Code: NKB
• UDI-Device Identifier: 04546540560889
• UDI-Public: 04546540560889
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48236053
• Device Catalogue Number: 48236053
• Device Lot Number: 172062
• 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
• Date Device Manufactured: 02/27/2017
• 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 Sex: Female