MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

Device retained by hospital.

Event Description

A physician reported that a patient is scheduled to undergo revision surgery to replace a fractured xia 4.5 vitallium rod.

Manufacturer Narrative

A3 and d6 have been updated to reflect new information.D4 has been corrected from w48132601 to 48132601.

Event Description

A physician reported that a patient was revised to replace a fractured xia 4.5 vitallium rod.

Manufacturer Narrative

The device was discarded and could not be evaluated.The lot number is unknown so neither a device history review or a complaint history review could be conducted.The original surgery date is unknown and it is unknown if the patient fused.X-rays were not provided.The ifu states: "the surgeon must warn the patient of the surgical risks and make aware of possible adverse effects.The surgeon must warn the patient that the devices cannot and do not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implants can break or become damaged as a result of strenuous activity or trauma, and that the devices 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 advise the patient that resultant forces can cause failure of the devices.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." there is not enough information provided to determine an exact root cause.Possible root causes from the ifu and risk file include excessive post op activity, patient fall, poor construct design, overtightening, poor bone quality, fusion/lack of fusion, and/or rod too stiff.

Event Description

A physician reported that a patient was revised to replace a fractured xia 4.5 vitallium rod.

• Brand Name: XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10370429
• MDR Text Key: 201836583
• Report Number: 0009617544-2020-00133
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K121342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: 48132601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention