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

Catalog Number 48811228

Device Problems Bent (1059); Mechanical Problem (1384); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 11/10/2015

Event Type  malfunction  

Event Description

It is reported that; 28mm aviator plate locking mechanism bent during plate bending & screw insertion.

Manufacturer Narrative

Method: device history review; complaint history review; risk assessment; results: manufacturing files were reviewed and no anomalies were found.No additional information was provided and no product was returned to aid in the investigation.Conclusion: the root cause is the root cause is not determined.

Event Description

It is reported that; 28mm plate locking mechanism bent during plate bending & screw insertion.

Manufacturer Narrative

Results: manufacturing files were reviewed and no anomalies were found.The stryker rep reported that the plate was contoured between the holes and not unbent, and that the holes were prepared freehand.Conclusion: the probable root cause is not preparing the screw hole with a drill guide (free handing) as recommended by the surgical technique.

Event Description

It is reported that; 28mm plate locking mechanism bent during plate bending & screw insertion.

• 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5273071
• MDR Text Key: 33376750
• Report Number: 0009617544-2015-00520
• Device Sequence Number: 1
• Product Code: KWQ
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2015

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 Catalogue Number: 48811228
• Device Lot Number: 155358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 12/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/18/2016; 09/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2015
• 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