MAUDE Adverse Event Report: STRYKER SPINE-US OASYS BLOCKER; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number 48551000

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  Injury  

Event Description

It was reported that a patient was revised approximately 2 weeks after implantation to address the migration of four oasys blockers.From the imaging provided, it was also observed that a tulip of one unknown oasys screw has disengaged.This report captures the fourth of four blockers.

Manufacturer Narrative

H6 coding has been updated to reflect completion of the investigation.

Event Description

It was reported that a patient was revised approximately 2 weeks after implantation to address the migration of four oasys blockers.From the imaging provided, it was also observed that a tulip of one unknown oasys screw has disengaged.This report captures the fourth of four blockers.

• Brand Name: OASYS BLOCKER
• 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: 18518561
• MDR Text Key: 332933404
• Report Number: 0009617544-2024-00005
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 04546540371508
• UDI-Public: 04546540371508
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48551000
• Device Lot Number: E96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2022
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male