MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT

Catalog Number UNK_SPN

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Dizziness (2194); Malaise (2359); Reaction (2414); Neck Pain (2433)

Event Date 07/13/2016

Event Type  Injury  

Event Description

It was reported that; patient had cervical fusion over a year ago using a device.She is complaining of symptoms of malaise, dizziness, facial swelling and neck pain which might be indications of allergy to titanium, vandadium, or aluminum of the device.

Manufacturer Narrative

Risk assessment; manufacturing files were not reviewed because the plate remains implanted.There were no new hazard/harms identified or breach of severity.This event was reviewed by a surgeon.According to the surgeon who reviewed this event, it is highly unlikely and there are no reports in the literature for titanium allergy related to spinal implants, including cervical plates.

Event Description

It was reported that; patient had cervical fusion over a year ago using a device.She is complaining of symptoms of malaise, dizziness, facial swelling and neck pain which might be indications of allergy to titanium, vanadium, or aluminum of the device.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN
• 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: 5858417
• MDR Text Key: 51712180
• Report Number: 0009617544-2016-00326
• 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: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2016
• 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