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

Model Number 48552430

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem Spinal Cord Injury (2432)

Event Date 03/01/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

H6 coding has been updated to reflect completion of the investigation.H3 other text : no product returned.

Event 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
• Type of Device: 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
• MDR Text Key: 311412445
• Report Number: 0009617544-2023-00008
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540371836
• UDI-Public: 04546540371836
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K151755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention