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

Catalog Number 48811228

Device Problems Break (1069); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 09/12/2016

Event Type  malfunction  

Event Description

It was reported that; two 28mm anterior cervical plates had the locking mechanism brake during screw insertion.The third 28mm plate was inserted successfully.

Manufacturer Narrative

Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing files were reviewed and no anomalies were found.Conclusion: the probable root cause of the mechanism popping up is not determined and multifactoral.

Event Description

It was reported that; two 28mm anterior cervical plates had the locking mechanism brake during screw insertion.The third 28mm plate was inserted successfully.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 28
• Type of Device: SPINAL 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5999833
• MDR Text Key: 57176442
• Report Number: 0009617544-2016-00401
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152187
• UDI-Public: (01)07613252152187
• 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: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48811228
• Device Lot Number: 168418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• 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