FDA Adverse Event Injury Summary report: N

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

MDR report key: 1694221 · Received May 18, 2010

Report

Report Number: 1030489-2010-00654
Event Type: Injury
Date Received: May 18, 2010
Report Date: April 20, 2010
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Product Code: KWQ
PMA / PMN Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B) (4): THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE LOT# H08M1325 AND W07M0799. G5: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 876-310, 510K # K970806 WAS CLEARED IN THE UNITED STATES. MANUFACTURE INFORMATION FOR LOT H08M1325 IS UNDER REQUESTING. THE FOLLOW UP REPORT WILL BE SENT AFTER THE INFORMATION IS AVAILABLE. MANUFACTURE DATE FOR LOT W07M0799 IS 12/17/2007. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR LOT W07M0799 WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PT UNDERWENT A PROCEDURE USING ANTERIOR PLATE FIXATION SYSTEM IN 2009. FUSION OCCURRED TO THE PT, BUT THE SCREW WAS FOUND BACKED OUT. THE REMOVAL SURGERY WAS PERFORMED DUE TO THE BACKED OUT SCREW. NO OTHER INFO IS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM	BONE SCREW	KWQ	MEDTRONIC SOFAMOR DANEK USA, INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	EXPLANT DATE:\| CERVICAL PLATE\| IMPLANT DATE: