FDA Adverse Event Injury Summary report: N

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

MDR report key: 2143361 · Received June 29, 2011

Report

Report Number: 1030489-2011-00825
Event Type: Injury
Date Received: June 29, 2011
Report Date: May 30, 2011
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: KWQ
PMA / PMN Number: UNK
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE USING ANTERIOR CERVICAL PLATE FIXATION SYSTEM. AFTER THE SURGERY, THE PATIENT HAD MILD DYSPHAGIA, AND FUSION REPORTEDLY WAS COMPLETE. TWO YEARS POST OP, THE PATIENT CAME BACK TO THE HOSPITAL BECAUSE OF THROAT IRRITATION. THE POLYP WAS FOUND BY ANOTHER HOSPITAL. REPORTEDLY, IT WAS FOUND ONE OF THE SCREWS WAS MISSING FROM THE CONSTRUCT AND IT WAS NOT FOUND IN THE PATIENT BODY BY X-RAYS. AFTER THAT, THE PATIENT WENT TO THE HOSPITAL WHERE HIS POLYP WAS FOUND. THE PATIENT UNDERWENT A PHYSICAL THERAPY FOR HIS POLYP IN THE THROAT. THE THROAT IRRITATION REPORTEDLY SUBSIDED AFTER THE PHYSICAL THERAPY. IT WAS REPORTED THAT THE PATIENT COUGHED OUT A SCREW FROM HIS MOUTH RECENTLY. THE PATIENT UNDERWENT A SURGERY TO REMOVE THE IMPLANTS ON SIX YEARS AFTER THE IMPLANTATION BECAUSE THE IMPLANTS WERE LOOSENED. THE PATIENT CURRENTLY IS HAVING ESOPHAGEAL ABSCESS WITH NO OTHER SYMPTOMS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWQ	MEDTRONIC SOFAMOR DANEK	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	00065 YR		Hospitalization\| R	PLATE