MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 4.0 X 28MM PA SCREW MEDIAL; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	48555428
Medical Device Problem Codes	Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that four oasys polyaxial screws were difficult to insert and that the tulips of all four screws disengaged intra-operatively.The procedure was completed successfully with a two hour surgical delay.This report captures the second of four oasys screws.
Event or Problem Description
Inspection of the returned devices indicates that the tulips of two out of the four oasys polyaxial screws were not disengaged.This report captures the second of four oasys screws, and a screw without a disengaged tulip.
Additional Manufacturer Narrative
Corrected data: b5, d1.Additional data: d4, d9, h3, h4.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: OASYS 4.0 X 28MM PA SCREW MEDIAL
• Common Device Name: POSTERIOR CERVICAL 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: 21510698
• Report Number: 0009617544-2025-00017
• Device Sequence Number: 17268335
• Product Code: NKG
• UDI-Device Identifier: 04546540469625
• UDI-Public: (01)04546540469625(11)220829(10)223824
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151755
• 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): 06/20/2025

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 Catalogue Number: 48555428
• Device Lot Number: 223824
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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