MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 4.0 X 26MM POLYAXIAL SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	48552426
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tulip of an oasys polyaxial screw disengaged post-operatively.Upon review of x-ray imaging provided, it was observed that an oasys connector and an oasys rod also migrated.A revision surgery is not currently scheduled but may be performed.This report captures the polyaxial screw.
Additional Manufacturer Narrative
Corrected data: b5.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A company representative reported that the tulip of an oasys polyaxial screw disengaged post-operatively.Upon review of x-ray imaging provided, it was observed that a denali adjustable transverse connector and an oasys rod also migrated.A revision surgery is not currently scheduled but may be performed.This report captures the polyaxial screw.

• Brand Name: OASYS 4.0 X 26MM POLYAXIAL SCREW
• 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 24519735
• Report Number: 0009617544-2026-00028
• Device Sequence Number: 18572943
• Product Code: NKG
• UDI-Device Identifier: 04546540371829
• UDI-Public: 04546540371829
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/01/2026

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: 48552426
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown