MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 12; INAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Model Number 48811112

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2017

Event Type  malfunction  

Event Description

It was reported that; 12 mm plate spring bar was deformed while surgeon was implanting.Back up 12 mm plate was used.

Manufacturer Narrative

The aviator plate deformation was confirmed via visual inspection.The plate was confirmed to have a spring bar deformed.No relevant manufacturing issues were identified as all units met stryker specifications.The plausible root cause of the event was determined to be using a freehand technique during holes preparation.It is recommended to use variable or fixed drill guide to ensure the proper angulation of the screw so as not to damage the spring bar.

Event Description

It was reported that; 12 mm plate spring bar was deformed while surgeon was implanting.Back up 12 mm plate was used.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 12
• Type of Device: INAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: marta koutsogiannis ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6681584
• MDR Text Key: 79128754
• Report Number: 0009617544-2017-00274
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152101
• UDI-Public: (01)07613252152101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

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
• Device Operator: No Information
• Device Model Number: 48811112
• Device Catalogue Number: 48811112
• Device Lot Number: 170932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 06/08/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1