MAUDE Adverse Event Report: STRYKER SPINE-US OASYS MIDLINE OCCIPUT PLATE ASSY MEDIUM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	48551045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised to address a fractured oasys occipital plate.
Event or Problem Description
It was reported that a patient was revised to address a fractured oasys occipital plate.

• Brand Name: OASYS MIDLINE OCCIPUT PLATE ASSY MEDIUM
• 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: 17430950
• Report Number: 0009617544-2023-00060
• Device Sequence Number: 15146320
• Product Code: NKG
• UDI-Device Identifier: 04546540616548
• UDI-Public: 04546540616548
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 12/05/2023

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 Catalogue Number: 48551045
• Device Lot Number: 208086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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: 74 YR
• Patient Sex: Male