MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 6.5X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482804645

Device Problem Biocompatibility (2886)

Patient Problem Injury (2348)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

Hospital discarded device.

Event Description

A surgeon reported that a patient may have experienced metallosis at the l4 level whilst implanted with two es2 screws and two es2 hex rods.The patient was undergoing a scheduled revision surgery to extend the construct to s1 when the surgeon noted, "metallosis around the l4 screws," and, "some evidence of discolouration of the surrounding tissue adjacent to the screws." surgery was completed as planned; the rods were explanted and replaced with longer rods and the l4 screws were replaced.This report represents the first of the two screws.

Manufacturer Narrative

Visual, dimensional, functional and material analysis could not be performed as the device was not returned.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.An exact root cause of the reported event could not be determined.Potential causes include: surgeon damaged surrounding soft tissue implant irritates soft tissue incorrect implant size selected patient pathology.

Event Description

A surgeon reported that a patient may have experienced metallosis at the l4 level whilst implanted with two es2 screws and two es2 hex rods.The patient was undergoing a scheduled revision surgery to extend the construct to s1 when the surgeon noted, "metallosis around the l4 screws," and, "some evidence of discolouration of the surrounding tissue adjacent to the screws." surgery was completed as planned; the rods were explanted and replaced with longer rods and the l4 screws were replaced.This report represents the first of the two screws.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 6.5X45MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10254814
• MDR Text Key: 198318949
• Report Number: 0009617544-2020-00122
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327002188
• UDI-Public: 07613327002188
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482804645
• Device Catalogue Number: 482804645
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR