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

Model Number	482804645
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital discarded device.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10254814
• Report Number: 0009617544-2020-00122
• Device Sequence Number: 19477204
• Product Code: NKB
• UDI-Device Identifier: 07613327002188
• UDI-Public: 07613327002188
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 482804645
• Device Catalogue Number: 482804645
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR