MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 32MM PA SCREW SMOOTH SHANK; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48556332
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a patient presented with pain, an mri was performed and an oasys polyaxial screw was observed to be fractured post-operatively.Revision surgery was performed to remove the broken oasys screw.During surgery it was noticed that another screw was fractured on the right side.The broken tulips of both screws were removed, however, the surgeon was not able to remove the threads of both screws.The threaded part of the screws remained in the bone and new screws were placed in parallel.This report represents the oasys screw.
Event or Problem Description
It was reported that after a patient presented with pain, an mri was performed and an oasys polyaxial screw was observed to be fractured post-operatively.Revision surgery was performed to remove the broken oasys screw.During surgery it was noticed that another screw was fractured on the right side.The broken tulips of both screws were removed, however, the surgeon was not able to remove the threads of both screws.The threaded part of the screws remained in the bone and new screws were placed in parallel.This report represents the oasys screw.
Additional Manufacturer Narrative
The screw was inspected visually and was confirmed to be fractured, with the threaded portion of the shank fractured off.The fractured piece was left inside the patient.Mri was also provided showing the fractured screw.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.Complaint history records were also reviewed for this lot and no similar complaints were identified.It was reported that the screw was implanted for a period of 10 months.Fusion was not performed as osteosynthesis was performed for older atlas fractures and dens fractures with space-occupying pseudarthrosis without consolidation tendencies.The patient has osteoporotic soft bone and is described as very active.The revision revealed that the patient's fractures were still not consolidating.From the oasys ifu: the surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.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.Contraindications: any abnormality present, which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, active infection at the site or certain metabolic disorders affecting osteogenesis.Based on the information provided, the root cause is multifactorial, with poor bone quality and lack of fusion along with the patient's activity level contributing to the screw eventually fracturing due to continued movement in the construct over time.

• Brand Name: OASYS 3.5 X 32MM PA SCREW SMOOTH SHANK
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10387337
• Report Number: 0009617544-2020-00136
• Device Sequence Number: 2898499
• Product Code: NKG
• UDI-Device Identifier: 04546540469755
• UDI-Public: 04546540469755
• Combination Product (Y/N): N
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 48556332
• Device Catalogue Number: 48556332
• Device Lot Number: 18A645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 65