MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482802740

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Status and location of the device is currently unknown.

Event Description

It was reported that a patient received revision surgery approximately four months post operatively due to a loose screw.During the revision surgery, the surgeon found that an es2 integrated blade screw tulip disengaged and a blocker migrated.The screws were then replaced and the construct was extended.This report represents the es2 integrated blade screw.

Event Description

It was reported that a patient received revision surgery approximately four months post operatively due to a loose screw.During the revision surgery, the surgeon found that an es2 integrated blade screw tulip disengaged and a blocker migrated.The screws were then replaced and the construct was extended.This report represents the es2 integrated blade screw.

Manufacturer Narrative

Visual, dimensional, functional and material analysis could not be performed as the device was not returned.A review of the complaint and device history records could not be performed as a valid lot number was not provided and could not be obtained.Per es2 surgical technique: the surgeon must warn the patient of the surgical risks and made aware of possible adverse effects.The surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device 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 device.Patients who smoke have been shown to have an increased incidence of non-unions.Notes from initial surgery were not provided.It is unknown how screw holes were prepared during initial surgery and how final tightening was performed.It is unknown if the screws were over angulated or blocker was over tightened.Patient's bone quality and activity levels are unknown.Due to lack of information and product not returned, exact cause could not be determined.Potential causes include: incorrect device placement, excessive patient post-op activities, insufficient final locking/tightening, surgeon applying too much torque to tighten the blockers, poor fixation construct, etc.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10701977
• MDR Text Key: 212104075
• Report Number: 0009617544-2020-00174
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327002003
• UDI-Public: 07613327002003
• Combination Product (y/n): N
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

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
• Device Operator: Health Professional
• Device Model Number: 482802740
• Device Catalogue Number: 482802740
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR