MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; UNKNOWN SPINE AVIATOR

Catalog Number UNK_SPN

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Unspecified Infection (1930); Injury (2348)

Event Date 12/01/2016

Event Type  Injury  

Event Description

It was reported that; the screw backed out in (b)(6) causing an esophageal tear and subsequently the patient was revised.After the patient was revised, it was reported that the patient developed an infection.Subsequent communication between the rep and the surgeon was that the patient had passed.There is no indication at this point that there is a correlation between the screw backing out and the patient¿s passing.

Manufacturer Narrative

Visual inspection, functional inspection, was not performed because the parts were not returned.Multiple attempts were made through the sales rep and the surgeon's nurse to obtain additional information on this case and unfortunately the surgeon was not willing to provide this information.If additional information and/or the explanted screw become available, this investigation will be reopened and updated.

Event Description

It was reported that; the screw backed out in december causing an esophageal tear and subsequently the patient was revised.After the patient was revised, it was reported that the patient developed an infection.Subsequent communication between the rep and the surgeon was that the patient had passed.There is no indication at this point that there is a correlation between the screw backing out and the patient¿s passing.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN SPINE AVIATOR
• 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: 6824885
• MDR Text Key: 83811546
• Report Number: 0009617544-2017-00337
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• 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): Other; Required Intervention