MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 22MM POLYAXIAL SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	48552322
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a revision surgery for oasys blocker and screw migration, it was noticed that one oasys polyaxial screw had fractured.Re-revision is not scheduled.
Additional Manufacturer Narrative
H3 other text : device remains implanted.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
It was reported that after a revision surgery for oasys blocker and screw migration, it was noticed that one oasys polyaxial screw had fractured.Re-revision is not scheduled.

• Brand Name: OASYS 3.5 X 22MM 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 18991044
• Report Number: 0009617544-2024-00031
• Device Sequence Number: 11522635
• Product Code: NKG
• UDI-Device Identifier: 04546540371720
• UDI-Public: 04546540371720
• 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: 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): 06/28/2024

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: 48552322
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 06/28/2024
• 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 Age: 75 YR
• Patient Sex: Male