MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM CP TI L 480MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 48232480

Device Problem Fracture (1260)

Patient Problems Pain (1994); Immunodeficiency (2156); Stenosis (2263); Paraplegia (2448)

Event Date 11/08/2021

Event Type  Injury  

Manufacturer Narrative

Visual, dimensional, material and functional 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.All the available information was reviewed with a stryker medical professional who concluded that this event represents a pseudarthrosis case.The failed fusion was most likely due to the patients¿ comorbidities and the length of the construct.The xia 3 surgical technique was reviewed, and the following information was found to be relevant: "while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.Once implanted, the implants are subjected to stresses and strains.These repeated stresses on the implants should be taken into consideration by the surgeon at the time of the choice of the implant, during implantation as well as in the post-operative follow-up period.Indeed, the stresses and strains on the implants may cause metal fatigue or fracture or deformation of the implants before the bone graft has become completely consolidated.This may result in further side effects or necessitate the early removal of the osteosynthesis device.Surgeons must instruct patients regarding appropriate and restricted activities during consolidation and maturation for the fusion mass in order to prevent placing excessive stress on the implants which may lead to fixation or implant failure and accompanying clinical problems".The most likely cause of the reported event based on the information available is patient's comorbidities, lack of fusion and the length of the construct.

Event Description

In (b)(6) of 2020 the patient had an initial surgery to address tuberculous spondylitis and stenosis of the vertebral canal.Two months later, they went on to have two revision surgeries not related to the hardware but to address their comorbidities.It was then reported that approximately 9 months post-operatively from the initial surgery the patient presented with back pain and an audible "crunch" from the construct site.A ct scan revealed that the left xia 3 rod had fractured.It has not been reported if revision surgery has been scheduled or performed at this time.

Manufacturer Narrative

Section a has been updated with new patient information received.Section h6, clinical signs code grid and health impact code grid, have been updated with new information received.Following a consultation with a phthisiologist, new information on december 8, 2021 regarding the patient's post-operative condition and compliance has been received.The patient is experiencing "lower flaccid paraparesis with mild motor disorders in the right lower limb and pronounced motor disorders in the left lower limb, up to plegia in the foot.Secondary vertebral syndrome.Bilateral lumbalgia".The phthisiologist concluded that "according to the presented ct scan of the spine, the patient has a fracture of the rod of the fixing structure on the left.Probably due to non-compliance with the orthopedic regime and the lack of proper spine corsets".

Event Description

In (b)(6) 2020 the patient had an initial surgery to address tuberculous spondylitis and stenosis of the vertebral canal.Two months later, they went on to have two revision surgeries not related to the hardware but to address their comorbidities.It was then reported that approximately 9 months post-operatively from the initial surgery the patient presented with back pain and an audible "crunch" from the construct site.A ct scan revealed that the left xia 3 rod had fractured.It has not been reported if revision surgery has been scheduled or performed at this time.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM CP TI L 480MM
• Type of Device: 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: 12956669
• MDR Text Key: 281908200
• Report Number: 0009617544-2021-00228
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540560575
• UDI-Public: 04546540560575
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48232480
• Device Catalogue Number: 48232480
• Device Lot Number: 6M4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 51 KG