MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482804650
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported revision surgery to explant a migrated tritanium pl cage and a fractured es2 integrated blade screw.The patient reported experiencing pain.This report captures the es2 integrated blade screw.
Additional Manufacturer Narrative
D10 has been corrected form 'no' to 'return'.H3 has been corrected from 'no" to 'yes'.Visual inspection: visual inspection confirmed fractured screw at threading/main body.Fractured tip was not returned as it remains implanted in the patient.Device and complaint history records were reviewed, no relevant manufacturing issues or no similar complaints were identified.From es2 surgical technique: per final tightening of the construct, turn the handle of the torque wrench clockwise to align the two arrows on the torque wrench to achieve the 12nm of torque required to secure the implant construct.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.Inspection of the screw revealed a large dent on screw shank head indicating over tightening of blocker during initial surgery.Based on inspection of returned part, most likely cause of reported event is blocker over tightening.
Event or Problem Description
A physician reported revision surgery to explant a migrated tritanium pl cage and a fractured es2 integrated blade screw.The patient reported experiencing pain.This report captures the es2 integrated blade screw.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9167056
• Report Number: 0009617544-2019-00115
• Device Sequence Number: 447851
• Product Code: NKB
• UDI-Device Identifier: 07613327002195
• UDI-Public: 07613327002195
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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 Catalogue Number: 482804650
• Device Lot Number: 18A316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 86