MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 5.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482802540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned per hospital policy.
Event or Problem Description
Primary surgery using es2 system was performed (b)(6) 2017.It was reported that the screw deviated from the vertebral body post-operatively and the cage fractured at l3/4.Patient was revised on (b)(6) 2019.This record represents the cage.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed no relevant issues or similar events were identified.Due to lack of information and as the screw was not returned, a definite root cause cannot be determined but may have occurred potentially due to incorrect screw trajectory, wrong instrument used for screw final tightening, poor bone quality / patient pathology, excessive post-op activity by patient (not recommended by surgeon), screw threads are worn/stripped.Additionally, the screw was implanted for almost 2 years and it is unknown if the patient fused.According to the ifu, "in the event that healing is delayed, does not occur, or failure to immobilize the delayed/ nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture." h3 other text : device was not returned and therefore could not be evaluated.
Event or Problem Description
Primary surgery using es2 system was performed (b)(6) 2017.It was reported that the screw deviated from the vertebral body post-operatively and the cage fractured at l3/4.Patient was revised on (b)(6) 2019.This record represents the cage.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 5.5X40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8724915
• Report Number: 3004024955-2019-00026
• Device Sequence Number: 2022396
• Product Code: NKB
• UDI-Device Identifier: 07613327001884
• UDI-Public: 07613327001884
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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: No Information
• Device Catalogue Number: 482802540
• Device Lot Number: 163988
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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