MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY THREE LEVEL PLATE SIZE 48; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48811348
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Notified by surgeon that screw appears to be backing out of cervical plate.Surgeon will commit us observation of hardware.
Additional Manufacturer Narrative
Method: labelling review, risk assessment.Results: the plate was confirmed to have a screw migrated post op.A revision surgery has occurred and the screw was retightened back into the plate.The patient's lifestyle, bone quality and activity level is unknown as well as any details from the initial surgery.Manufacturing files were not reviewed because no lot or parts were provided.No inspection was performed as the devices are implanted in the patient.Conclusion: as reported, the plate was found locked and the screws were above the spring bar so the probable root cause not implanting the screw under the spring bar as directed by the surgical technique guide, "when screws are fully inserted within the allowed range of angulation, the spring bar can then expand over the screw head.Once the spring bar is positioned over the screw heads, the blocker should be rotated to secure the spring bar over the screws.".
Event or Problem Description
Notified by surgeon that screw appears to be backing out of cervical plate.Surgeon will commit us observation of hardware.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 48
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7456250
• Report Number: 0009617544-2018-00086
• Device Sequence Number: 13726199
• Product Code: KWQ
• UDI-Device Identifier: 07613252152293
• UDI-Public: (01)07613252152293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: No Information
• Device Model Number: 48811348
• Device Catalogue Number: 48811348
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1