MAUDE Adverse Event Report: STRYKER SPINE-US OASYS MIDLINE OCCIPUT PLATE ASSY SMALL; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48551044
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Neuropathy (1983)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was lost after cleaning.
Event or Problem Description
It was reported that an oasys midline occiput plate fractured at the tulip approximately 5 months post-operatively.The patient did not fuse and has experienced neurological effects as a result of this event.Revision surgery has been performed.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, xrays were provided showing the tulip had fractured from the plate.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The patient activity level is unknown and was reported to not have fallen.It was reported the patient did not fuse and was compliant with post op mobilization.No complications were reported in the initial procedure.Screw holes were drilled and tapped and the drill guide was used.Plate was not bent.As the plate was not returned, a definite cause cannot be determined.Possible 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 an oasys midline occiput plate fractured at the tulip approximately 5 months post-operatively.The patient did not fuse and has experienced neurological effects as a result of this event.Revision surgery has been performed.

• Brand Name: OASYS MIDLINE OCCIPUT PLATE ASSY SMALL
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11030202
• Report Number: 0009617544-2020-00209
• Device Sequence Number: 19757799
• Product Code: NKG
• UDI-Device Identifier: 04546540616531
• UDI-Public: 04546540616531
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 48551044
• Device Catalogue Number: 48551044
• Device Lot Number: 144302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 04/27/2021
• 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