MAUDE Adverse Event Report: STRYKER SPINE-US 8.5X80 MEDIAL BIASED ANGLE POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482678580
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tulip of a xia serrato polyaxial screw disengaged intra-operatively when attempting to remove the screw.It was further reported that the bone around the screw was cut with a chisel in order to remove the screw, and that the widened screw hole was reinforced with a hydroxyapatite stick.A larger screw was then inserted to complete the procedure.
Additional Manufacturer Narrative
Additional data: d9, h3.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: 8.5X80 MEDIAL BIASED ANGLE 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 22032638
• Report Number: 0009617544-2025-00047
• Device Sequence Number: 15805630
• Product Code: NKB
• UDI-Device Identifier: 07613327351873
• UDI-Public: (01)07613327351873(11)180615(10)B83454
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/29/2025

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 Catalogue Number: 482678580
• Device Lot Number: B83454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2018
• 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; Other
• Patient Age: 67 YR
• Patient Sex: Male