MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5X26MM POLYAXIAL SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48552326
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the tulips of two oasys screws, placed at left-side c3 and c4, became disengaged during explant surgery.The devices had been implanted for approximately 10 years and were being removed as part of a procedure to replace the older devices and extend the construct.The physician could not remove the screw shafts and elected to leave them implanted and begin the new, extended construct at c5.This report captures the screw implanted at c3.
Event or Problem Description
A physician reported that the tulips of two oasys screws, placed at left-side c3 and c4, became disengaged during explant surgery.The devices had been implanted for approximately 10 years and were being removed as part of a procedure to replace the older devices and extend the construct.The physician could not remove the screw shafts and elected to leave them implanted and begin the new, extended construct at c5.This report captures the screw implanted at c3.
Additional Manufacturer Narrative
Visual inspection of the returned device confirms that tulip head was disengaged from screw shank.Device history records were reviewed for this lot and no relevant manufacturing issues were found.Complaint history was reviewed and no similar complaints for this lot were identified.It was reported that device had been implanted for over 10 years.The ifu states: "while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials, which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors, which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.".

• Brand Name: OASYS 3.5X26MM POLYAXIAL SCREW
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11556102
• Report Number: 0009617544-2021-00037
• Device Sequence Number: 19790809
• Product Code: NKG
• UDI-Device Identifier: 04546540380524
• UDI-Public: 04546540380524
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 48552326
• Device Catalogue Number: 48552326
• Device Lot Number: 052100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 05/30/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1