MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 28; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48811228
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient required a revision surgery.The locking tab on the plate was broken upon going into surgery after the surgeon noticed the screws at c7 were backing out of the plate.
Event or Problem Description
It was reported that the patient required a revision surgery.The locking tab on the plate was broken upon going into surgery after the surgeon noticed the screws at c7 were backing out of the plate.
Additional Manufacturer Narrative
The event was confirmed by the stryker rep.A revision surgery occurred and the implants were kept by the hospital.Manufacturing files were not reviewed because no lot numbers were provided the root cause could not be determined from the information provided.Potential root causes include: poor surgical candidate or bone quality.Excessive post-op activity by patient (not recommended by surgeon).Patient does not follow surgeon instructions.Patient over exerts.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 28
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7347920
• Report Number: 0009617544-2018-00070
• Device Sequence Number: 18971523
• Product Code: KWQ
• UDI-Device Identifier: 07613252152187
• UDI-Public: (01)07613252152187
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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: No Information
• Device Model Number: 48811228
• Device Catalogue Number: 48811228
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 03/18/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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