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

Model Number	482802540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision surgery, the screw broke.There was no associated surgical delay.The procedure was completed with the broken part remaining in the bone.The cause of revision surgery is unknown.
Additional Manufacturer Narrative
Section were corrected to device product problem/ malfunction.The cause of revision surgery remains unknown.The screw fractured during removal and there is no indication that it was the cause of revision surgery to the patient.Method: visual inspection, device history review, complaint history review, risk assessment; result: device was confirmed to have its shaft fractured as reported.Broken fragment was left in the patient.No adverse consequences to the patient was reported at this time.Manufacturing history was reviewed and no issues were identified.Conclusion: potential root causes of the reported event: too much force applied when removing construct, screw pathway not prepared adequately or screw over angulated while removing the implant from the patient.
Event or Problem Description
It was reported that during a revision surgery, the screw broke.There was no associated surgical delay.The procedure was completed with the broken part remaining in the bone.The cause of revision surgery is unknown.

• 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: 7444968
• Report Number: 0009617544-2018-00085
• Device Sequence Number: 1949483
• Product Code: NKB
• UDI-Device Identifier: 07613327001884
• UDI-Public: (01)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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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 Model Number: 482802540
• Device Catalogue Number: 482802540
• Device Lot Number: 164452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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