MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 240MM ROD; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48552240
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
A physician reported that a patient experienced post-operative fracture of an oasys rod.The patient has been hospitalized.
Event or Problem Description
A physician reported that a patient experienced post-operative fracture of an oasys rod.The patient has been hospitalized.Revision surgery has occurred.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per oasys surgical technique: 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.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.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the device.Patients who smoke have been shown to have an increased incidence of non-unions.Exact cause could not be determined due to lack of information.Potential causes include: fatigue overload, non fusion, patient fall or excess post-op activity.

• Brand Name: OASYS 3.5 X 240MM ROD
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10478542
• Report Number: 0009617544-2020-00144
• Device Sequence Number: 3003628
• Product Code: NKG
• UDI-Device Identifier: 04546540371652
• UDI-Public: 04546540371652
• Combination Product (Y/N): N
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: 48552240
• Device Catalogue Number: 48552240
• Device Lot Number: ZG8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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: Other; Required Intervention
• Patient Weight: 90