MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 32; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 48811232

Device Problems Bent (1059); Material Deformation (2976)

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

Event Date 05/05/2016

Event Type  malfunction  

Event Description

It was reported that; plate was bent and implanted into the patient.After surgeon took an xray and upon closing, surgeon noticed the silver locking mechanism was deformed.Took the plate out and replaced with the same size plate.

Manufacturer Narrative

Lot# 157856.Method: visual inspection;device history review; complaint history review; risk assessment.Results: the device was confirmed to have a deformed spring bar resulting in a ten minute delay in surgery.Manufacturing files were reviewed and no anomalies were found.Conclusion: the stryker rep confirmed that no drill guides were used to prepare the screw holes and no revision driver was used to remove the screw for repositioning, so the cause is not using the recommended drill guides and revision drivers as per the stg.

Event Description

It was reported that; plate was bent and implanted into the patient.After surgeon took an xray and upon closing, surgeon noticed the silver locking mechanism was deformed.Took the plate out and replaced with the same size plate.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 32
• 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: 5673191
• MDR Text Key: 45811527
• Report Number: 0009617544-2016-00202
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152200
• UDI-Public: (01)07613252152200
• 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: 05/05/2016

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: 48811232
• Device Lot Number: 157856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• 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