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

Catalog Number 48811228

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 10/29/2015

Event Type  Injury  

Event Description

It has been reported that; patient had a 2 level acdf 2 years ago was having problems with her shoulder.Patient went in for an x-ray of her shoulder and that;s when it was noticed.

Manufacturer Narrative

Method:device history review; complaint history review; risk assessment; results: the stryker rep confirmed the age, height and weight of the patient.Based on a bmi calculation, the patient was found to be overweight.Conclusion: the root cause is patient related.

Event Description

It has been reported that; patient had a 2 level acdf 2 years ago was having problems with her shoulder.Patient went in for an x-ray of her shoulder and that's when it was noticed.

• 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: 5251032
• MDR Text Key: 32167401
• Report Number: 0009617544-2015-00500
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48811228
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 67