MAUDE Adverse Event Report: STRYKER SPINE-US RADIUS 5.5 X 40MM SPINAL ROD WITHOUT HEX; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 486613004

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Injury (2348)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

Two different catalog numbers with different lots were provided for the rod, the second number is 486613054 lot v58 (radius 5.5 x 40mm spinal rod without hex, spn); we will update our report with any changes upon additional information received.Device not returned from hospital.

Event Description

It was reported that patient underwent a revision surgery to replace a radius rod which migrated post-operatively.

Event Description

It was reported that patient underwent a revision surgery to replace a radius rod which migrated post-operatively.

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 the provided lot and no relevant manufacturing issues or similar complaints were identified.Per instructions for use: the surgeon must discuss all physical and psychological limitations inherent to the use of these devices with the patient.This includes the rehabilitation regimen, physical therapy, and wearing an appropriate orthosis as prescribed by the physician.Particular discussion should be directed to the issues of premature weight bearing, activity levels, and the necessity for periodic medical follow-up.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.Patients who smoke have been shown to have an increased incidence of non-unions.Surgeons must advise patients of this fact and warn of the potential consequences.For diseased patients with degenerative disease, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance.In such cases, orthopaedic devices may be considered only as a delaying technique or to provide temporary relief.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.Loosening of spinal fixation implants can occur.Early mechanical loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis, or trauma.Late loosening may result from trauma, infection, biological complications or mechanical problems, with the subsequent possibility of bone erosion, migration and/or pain.Late loosening may result from trauma, infection, biological complications or mechanical problems, with the subsequent possibility of bone erosion, migration and/or pain.As the device was not returned, and no x rays were provided, a definite root cause cannot be determined.Possible root causes include patient post-op activity, overtightening of the blockers, under tightening of the blockers, poor fixation construct, poor bone quality, and/or inadequate rod overhang.

• Brand Name: RADIUS 5.5 X 40MM SPINAL ROD WITHOUT HEX
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8946003
• MDR Text Key: 156012298
• Report Number: 3005525032-2019-00075
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 486613004
• Device Lot Number: 7MV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 50