MAUDE Adverse Event Report: STRYKER SPINE-LEESBURG SELF-TAPPING, VARIABLE SCREW; SIZE Ø4.0X14 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04014CA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the locking mechanism of an ozark plate disengaged at c5, and that two ozark self tapping variable screws have begun to migrate post operatively at the same level.No adverse consequences were reported.Revision surgery has not been performed nor scheduled at this time.This report is for one of the two ozark self tapping variable screws.
Additional Manufacturer Narrative
Device remains implanted.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.H3 other text : device remains implanted.
Event or Problem Description
It was reported that the locking mechanism of an ozark plate disengaged at c5, and that two ozark self-tapping variable screws have begun to migrate post-operatively at the same level.No adverse consequences were reported.Revision surgery has not been performed nor scheduled at this time.This report is for one of the two ozark self-tapping variable screws.

• Brand Name: SELF-TAPPING, VARIABLE SCREW; SIZE Ø4.0X14 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-LEESBURG; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): STRYKER SPINE-LEESBURG; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 16674305
• Report Number: 3004774118-2023-00040
• Device Sequence Number: 6379545
• Product Code: KWQ
• UDI-Device Identifier: 10888857392854
• UDI-Public: 10888857392854
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/27/2023

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 Model Number: 8801-04014CA
• Device Catalogue Number: 8801-04014CA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 07/27/2023
• 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
• Patient Age: 58 YR
• Patient Sex: Female