MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 26MM PA SCREW SMOOTH SHANK; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48556326
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 4 days post-operatively the head of an oasys smooth shank polyaxial screw had separated from the shank.The screw was removed during a revision surgery which lasted 3 hours.
Additional Manufacturer Narrative
Corrected data: d6a, d6b.Additional data: d4 , h4.
Event or Problem Description
It was reported that 4 days post-operatively the head of an oasys smooth shank polyaxial screw had separated from the shank.The screw was removed during a revision surgery which lasted 3 hours.

• Brand Name: OASYS 3.5 X 26MM PA SCREW SMOOTH SHANK
• 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: 16968677
• Report Number: 0009617544-2023-00030
• Device Sequence Number: 5492022
• Product Code: NKG
• UDI-Device Identifier: 07613327067606
• UDI-Public: 07613327067606
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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 Model Number: 48556326
• Device Catalogue Number: 48556326
• Device Lot Number: 059898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2006
• 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: Male