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

Model Number	482804745
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a patient implanted with es2 pedicle screws for a one level lumbar fusion presented with a surgical infection approximately one-month post-operatively.During removal of the implanted hardware it was discovered that tulip of an es2 long blade cannulated screw had disengaged.The tulip of the screw was explanted but the shaft of the screw was unable to be removed and was left in the pedicle.
Additional Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.
Event or Problem Description
A company representative reported that a patient implanted with es2 pedicle screws for a one level lumbar fusion presented with a surgical infection approximately one-month post-operatively.During removal of the implanted hardware it was discovered that tulip of an es2 long blade cannulated screw had disengaged.The tulip of the screw was explanted but the shaft of the screw was unable to be removed and was left in the pedicle.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 7.5X45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 16857579
• Report Number: 0009617544-2023-00019
• Device Sequence Number: 3428807
• Product Code: NKB
• UDI-Device Identifier: 07613327002232
• UDI-Public: 07613327002232
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 482804745
• Device Catalogue Number: 482804745
• Device Lot Number: 178045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male