MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5X26MM POLYAXIAL SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48552430
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Spinal Cord Injury (2432)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that the head of an oasys polyaxial screw fractured intra-operatively.The procedure was completed with an unknown surgical delay and the patient experienced spinal cord contusion, requiring dura repair and further hospitalization.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.H3 other text : no product returned.
Event or Problem Description
A company representative reported that the head of an oasys polyaxial screw fractured intra-operatively.The procedure was completed with an unknown surgical delay and the patient experienced spinal cord contusion, requiring dura repair and further hospitalization.

• Brand Name: OASYS 3.5X26MM 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: 16554371
• Report Number: 0009617544-2023-00008
• Device Sequence Number: 11518650
• Product Code: KWP
• UDI-Device Identifier: 04546540371836
• UDI-Public: 04546540371836
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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 Model Number: 48552430
• Device Catalogue Number: 48552326
• Device Lot Number: 177390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2017
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown