MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM22

Model Number	482802745
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a screw was originally implanted on (b)(6) 2017.Revision surgery was performed due to the head of the screw coming off of the tulip head.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment, x-rays.Result: the customer reported event was confirmed via visual inspection and x-ray images.Device was confirmed to have its tulip disengaged.The screw shank was found to be deformed.The one side of the opening ring of the tulip head that attached to the shank was also found to be deformed and the other side ring was fractured off.This indicates that the screw shaft was pressing against deformed side of the tulip head likely due to over angulation on screw, causing the screw shank to disengage and fracturing the other side ring.Conclusion: based on the x-ray image provided and the visual inspection on the returned product, it is likely that the screw tulip head disengaged due to over-angulation of the screw.
Event or Problem Description
It was reported that a screw was originally implanted on (b)(6) 2017.Revision surgery was performed due to the head of the screw coming off of the tulip head.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM22
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7347918
• Report Number: 0009617544-2018-00069
• Device Sequence Number: 1054899
• Product Code: NKB
• UDI-Device Identifier: 07613327002010
• UDI-Public: (01)07613327002010
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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: Health Professional
• Device Model Number: 482802745
• Device Catalogue Number: 482802745
• Device Lot Number: 172073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 03/18/2018
• Supplement Report FDA Received Date: 06/25/2018
• 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