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

Model Number	482802550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10298806
• Report Number: 0009617544-2020-00125
• Device Sequence Number: 17107095
• Product Code: NKB
• UDI-Device Identifier: 07613327001907
• UDI-Public: 07613327001907
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: 482802550
• Device Catalogue Number: 482802550
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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