MAUDE Adverse Event Report: STRYKER SPINE-US 7.5X45 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482617545
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We were provided two possible catalog numbers for the device and will update the record if we receive more information.The catalog number could be 482617545 or 482617550.H3 other text : device location unknown.
Event or Problem Description
A company representative reported that a patient underwent revision surgery approximately 6 months post-operatively to address a migrated tri pl cage and a 'loosened' xia polyaxial screw.This report is for the xia polyaxial screw.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.H3 other text : device location unknown.
Event or Problem Description
A company representative reported that a patient underwent revision surgery approximately 6 months post-operatively to address a migrated tri pl cage and a 'loosened' xia polyaxial screw.This report is for the xia polyaxial screw.

• Brand Name: 7.5X45 POLYAXIAL SCREW
• 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: 17058993
• Report Number: 0009617544-2023-00040
• Device Sequence Number: 8739323
• Product Code: NKB
• UDI-Device Identifier: 07613327351408
• UDI-Public: 07613327351408
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: 482617545
• Device Catalogue Number: 482617545
• Device Lot Number: C17495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian