MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 24MM PA SCREW MEDIAL; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48555324
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that two oasys pa medial screws fractured post-operatively.The surgeon has determined it is a high risk to remove fractured screws because of the cervical spine.The broken parts remain in the body with the consent of the patient.This report represents the first of the two screws.
Event or Problem Description
It was reported that two oasys pa medial screws fractured post-operatively.Revision surgery was performed but the broken devices remain implanted in the patient.This report represents the first of the two oasys pa medial screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device and complaint history records for this lot could not be performed as a valid lot code was not provided and could not be obtained.From the oasys ifu: the surgeon must discuss all physical and psychological limitations inherent to the use of the device with the patient.This includes the rehabilitation regimen, physical therapy, and wearing an appropriate orthosis as prescribed by the physician.Particular discussion must be directed to the issues of premature weightbearing, activity levels, and the necessity for periodic medical follow-up.The surgeon must warn the patient of the surgical risks and make the patient aware of possible adverse effects.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.As the device was not returned, a definite root cause cannot be determined.Based on the information provided, the patient's activity level along with the length of implantation contributed to the screw eventually fracturing due to continued movement in the construct over time.H3 other text: hospital retained.

• Brand Name: OASYS 3.5 X 24MM PA SCREW MEDIAL
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10833228
• Report Number: 0009617544-2020-00193
• Device Sequence Number: 19766108
• Product Code: NKG
• UDI-Device Identifier: 04546540469557
• UDI-Public: 04546540469557
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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: 48555324
• Device Catalogue Number: 48555324
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 02/08/2021
• 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