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); Neck Pain (2433)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The portion of the plate which captures the rod has broken off from the plate.The patient has a neck pain.A revision surgery will be required but not planned yet.
Event or Problem Description
The portion of the plate which captures the rod has broken off from the plate.The patient has a neck pain.A revision surgery will be required but not planned yet.
Additional Manufacturer Narrative
Additional information and correction: age: updated to 67 years.Sex: updated to male.Weight: information added.Lot # added.
Additional Manufacturer Narrative
Methods: visual and x-ray review confirmed fracture.Product history review confirmed lot 179958 was released on 06 oct 2017 without incident.Functional analysis could not be performed due to the plate was no longer functional, in addition, dimensional analysis was not performed as this was a reported fracture.The returned plate was confirmed to have fractured tulip (pins).Patients bone quality, activity level, and if fusion occurred is unknown.No material or manufacturing defects were found.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
The portion of the plate which captures the rod has broken off from the plate.The patient has a neck pain.A revision surgery will be required but not planned yet.

• 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: 8420211
• Report Number: 0009617544-2019-00024
• Device Sequence Number: 16686908
• Product Code: NKG
• UDI-Device Identifier: 04546540616531
• UDI-Public: 04546540616531
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 05/22/2019

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: 179958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 04/01/2019; 04/30/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/08/2019; 05/22/2019
• 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
• Patient Age: 67 YR
• Patient Weight: 96