MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 16MM POLYAXIAL SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	48552316
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Paresis (1998); Spinal Column Injury (2081)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that an oasys polyaxial screw migrated intra-operatively and perforated the patient's cortical bone.It was further reported that the patient's lateral mass fractured.The procedure was completed with no surgical delay.The patient was reported to have paralytic symptoms in their left upper limb two weeks post-operatively, and a revision surgery was subsequently performed.
Additional Manufacturer Narrative
Additional data: b5.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
The patient was reported to have rheumatism and poor bone quality.

• Brand Name: OASYS 3.5 X 16MM 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 22116657
• Report Number: 0009617544-2025-00052
• Device Sequence Number: 17164797
• Product Code: NKG
• UDI-Device Identifier: 04546540371690
• UDI-Public: 04546540371690
• 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): 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: 48552316
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 08/29/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian