MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 30; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48811230
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection, product history review, labelling review, risk assessment the plate was confirmed, by examination of the returned parts, to have a fractured locking mechanism post op.Manufacturing files were reviewed and no anomalies were found.Materials analysis was not performed as the fractured spring bar was a result of the screw backing out and removal of additional screws.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.
Event or Problem Description
It was reported that the plate spring bar popped off inside patient post op.Patient underwent revision to remove the plate and put a new one on with rescue screws.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 30
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8011565
• Report Number: 0009617544-2018-00249
• Device Sequence Number: 1435827
• Product Code: KWQ
• UDI-Device Identifier: 07613252254713
• UDI-Public: 07613252254713
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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: Health Professional
• Device Catalogue Number: 48811230
• Device Lot Number: 176660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 10/28/2018
• 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