MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 5.5X50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482802550

Device Problem Fracture (1260)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that an es2 integrated blade screw head fractured intra-operatively during a scheduled revision.While removing the screw on the bottom right side, the head of the screw broke off and the main body remained in the patient.The surgeon tried removing the rest of the screw but was unsuccessful.The surgeon had to close the wound with the broken screw left in the patient.

Manufacturer Narrative

Visual, dimensional, functional and material analysis could not be performed as the device was not returned because it remains implanted in the patient.A review of the device and complaint history records could not be performed as a valid lot number was not provided and could not be obtained.From es2 surgical technique: 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.These implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.Since the patient had fused, the implant had served its functional purpose.It is likely that the screw fractured due to fatigue on screw over the course of time.

Event Description

It was reported that an es2 integrated blade screw head fractured intra-operatively during a scheduled revision.While removing the screw on the bottom right side, the head of the screw broke off and the main body remained in the patient.The surgeon tried removing the rest of the screw but was unsuccessful.The surgeon had to close the wound with the broken screw left in the patient.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 5.5X50MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10298806
• MDR Text Key: 199658994
• Report Number: 0009617544-2020-00125
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327001907
• UDI-Public: 07613327001907
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482802550
• Device Catalogue Number: 482802550
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other