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

Model Number	7601-10001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product returned.
Event or Problem Description
A company representative reported that a patient was revised approximately 14 months after implantation to address two fractured yukon polyaxial screws at t1 and one migrated yukon set screw.This report is for the migrated yukon set screw.

• Brand Name: SET 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-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15815715
• Report Number: 3004774118-2022-00390
• Device Sequence Number: 7027824
• Product Code: NKG
• UDI-Device Identifier: 10888857328310
• UDI-Public: 10888857328310
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2022

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: 7601-10001
• Device Catalogue Number: 7601-10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Unknown