MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 30; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Model Number	48811230
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the surgeon performed a two level acdf on a patient he happen to touch the plate prior to closing the incision and realized there was something sharp protruding.He then noticed that the locking spring ring had popped out.
Additional Manufacturer Narrative
Manufacturing files were reviewed and no anomalies were found.The plate was confirmed visually to have a deformed spring bar.The plausible root cause is undetermined.
Event or Problem Description
It was reported that after the surgeon performed a two level acdf on a patient he happen to touch the plate prior to closing the incision and realized there was something sharp protruding.He then noticed that the locking spring ring had popped out.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 30
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6720066
• Report Number: 0009617544-2017-00287
• Device Sequence Number: 16455458
• Product Code: KWQ
• UDI-Device Identifier: 07613252152194
• UDI-Public: (01)07613252152194
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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: 48811230
• Device Catalogue Number: 48811230
• Device Lot Number: 166630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1