MAUDE Adverse Event Report: STRYKER SPINE-US OASYS MIDLINE OCCIPUT PLATE ASSY SMALL; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	48551044
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the two tulips on plate have disconnected from plate post-operatively.Revision surgery will be required.The patient was experiencing pain.
Additional Manufacturer Narrative
Visual inspection of the plate identified a small amount of intact fracture surfaces where the tulip pins fractured, an approximate origin was able to be established.Materials analysis was performed in a similar complaint and found that "each tulip pin have ductally fractured in a mode of reverse bending.The elemental constituents were consistent with what is specified on the print.No material or manufacturing defects were found¿.Product history and complaint history review on the reported lot was without incident and no prior complaints.It was reported that the patient was revised using a competitor product.The surgeon did not provide any additional information on this case.No complications in the surgery and the patient's pathology was unknown.The patient did not fuse, which is the probable root cause of the tulip separation.According to the ifu "these implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed".
Event or Problem Description
It was reported that the two tulips on plate have disconnected from plate post-operatively.Revision surgery will be required.The patient was experiencing pain.
Additional Manufacturer Narrative
Method: x-ray image review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed upon x-ray image review.The device was not returned, therefore the device evaluation could not be performed.Manufacturing files were not reviewed due to no parts or lot provided.Conclusion: the possible root causes include: improper construct, set screws not tightened correctly.Excessive load due to unstable construct.Excessive load due to patient anatomy/pathology.Patient performs strenuous post-op activities.Surgeon applying too much torque to seat the screw head.
Event or Problem Description
It was reported that the two tulips on plate have disconnected from plate post-operatively.Revision surgery will be required.The patient was experiencing pain.

• Brand Name: OASYS MIDLINE OCCIPUT PLATE ASSY SMALL
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8065411
• Report Number: 0009617544-2018-00266
• Device Sequence Number: 2434844
• Product Code: NKG
• UDI-Device Identifier: 04546540616531
• UDI-Public: 04546540616531
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2019

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 Catalogue Number: 48551044
• Device Lot Number: L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 01/30/2019; 05/30/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 02/28/2019; 06/06/2019
• 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