FDA Adverse Event Injury Summary report: N

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

MDR report key: 7501735 · Received May 10, 2018

Report

Report Number: 1030489-2018-00660
Event Type: Injury
Date Received: May 10, 2018
Report Date: May 10, 2018
Manufacturer: WARSAW ORTHOPEDICS
Product Code: KWQ
UDI-DI: 00613994625113
PMA / PMN Number: K021461
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. BELOW ADDITIONAL PRODUCTS WERE ALSO IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN WHICH OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. PRODUCT ID , LOT , 510K , UPN , QUANTITY ;3120513 , UNK , K063100 , (B)(4) ,6 . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY ON (B)(6) 2013. POST-OP, PATIENT WAS IN CHRONIC PAIN. PATIENT HAS REPORTEDLY PAIN IN NECK, THORACIC AND BACK WHICH HAS PROGRESSED THROUGHOUT THE BODY. PATIENT IS SENSITIVE TO NICKEL AND THE SENSITIVITY IS ALL TIME HIGH. PATIENT ALSO REPORTED TO HAVE ITCHING AND HAS HIVES DUE TO THIS ALLERGY. PATIENT REPORTED GASTRO ISSUES, MAJOR INFLAMMATION ALL OVER PATIENT'S BODY, EXTREME FATIGUE, SEVERE HEADACHES, SENSATION OF ELECTRICITY THAT FEELS LIKE IT IS BURNING & SHARP PAIN, EXTREME FATIGUE, DO NOT FEEL RIGHT AND MANY OTHER SYMPTOMS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
347595	ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	KWQ	WARSAW ORTHOPEDICS	NA	UNK	00613994625113

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other