FDA Adverse Event Malfunction Summary report: N

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

MDR report key: 1749228 · Received July 2, 2010

Report

Report Number: 1030489-2010-00872
Event Type: Malfunction
Date Received: July 2, 2010
Report Date: June 4, 2010
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Product Code: HWC
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE LOT OF THE SUSPECTED DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MFR CANNOT DETERMINE THE SUSPECT DEVICE. THE DEVICES THAT WERE USED ARE LOT H08M13215 AND W07M0799. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG #876-310, 510# K970806 WAS CLEARED IN THE UNITED STATES. THE MFR DATE FOR LOT H08M1325 IS (B)(4) 2009; THE MFR DATE FOR LOT W07M0799 IS (B)(4) 2007. PRE-OP LATERAL AND MULTIPLE POST-OP X-RAYS WERE TAKEN AFTER CORPECTOMY ANTERIORLY. THE PT UNDERWENT A SUBTOTAL CORPECTOMY AS WELL WITH TRICORTICAL ILIAC GRAFT SPANNING TWO DISC SPACES. DUE TO REMOVAL OF INTERIOR ENDPLATE PROXIMATELY, THE CONSTRUCT HAS COLLAPSED INTO FLEXION, TEARING THE BONE SCREWS OUT. SCREWS APPEAR TOO SHORT. GRAFT HAS PARTIALLY SUBLUXED VENTRALLY AS WELL. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PT UNDERWENT A CERVICAL PROCEDURE TO IMPLANT THE ANTERIOR PLATE AND SCREWS AT C3-C5. THE VARIABLE SCREW BACKED OUT AT C5 POST OP. THE REMOVAL SURGERY REPORTEDLY MIGHT BE REQUIRED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR			CERVICAL PLATE\| IMPLANT DATE: