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

Catalog Number	48555324
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
It was reported the 3.5 x 24 mm screw implanted in t2 broke post-operatively.The device remains implanted.No adverse consequences to the patient have been reported with this event and revision surgery is not planned at this time.
Additional Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device remains implanted in patient.Complaint history records were not reviewed as a valid lot number was not provided and could not be obtained.Manufacturing history records were not reviewed as a valid lot number was not provided and could not be obtained.It was confirmed via images provided that the thread of the screw fractured post-operatively.It is unknown if patient had a fall, or if the patient fused.No information on patient's pathology provided.It was reported that a revision surgery will be performed only if fusion is not achieved.The probable root cause of fracture could not be determined from the information provided.However if patient did not fuse (surgery was performed about a year ago) this may have contributed to fracture.Per the ifu statement: "the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.".
Event or Problem Description
It was reported the 3.5 x 24 mm screw implanted in t2 broke post-operatively.The device remains implanted.No adverse consequences to the patient have been reported with this event and revision surgery is not planned at this time.

• 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: 8584405
• Report Number: 0009617544-2019-00070
• Device Sequence Number: 1981937
• Product Code: NKG
• UDI-Device Identifier: 04546540469557
• UDI-Public: 04546540469557
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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 Catalogue Number: 48555324
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1