FDA Adverse Event Malfunction Summary report: N

VENTURE ANTERIOR CERVICAL PLATE SYSTEM

MDR report key: 2209875 · Received August 12, 2011

Report

Report Number: 1030489-2011-01040
Event Type: Malfunction
Date Received: August 12, 2011
Report Date: July 14, 2011
Manufacturer: MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
Product Code: KWQ
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATION.

Additional Manufacturer Narrative · 1

(B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 9791323, 510K # K061274 WAS CLEARED IN THE UNITED STATES. MULTIPLE AP AND LATERAL X-RAY OF CERVICAL SPINE SHOW EFFECT CORPECTOMY OF C5 WITH ANTERIOR FIXATION PLATE WITH SELF TAPPING SCREWS AT C4-C6. SUBSEQUENT FILMS SHOW COLLAPSE AND KYPHOSIS DEVELOPING WITH TOGGLE OF SUPERIOR SCREWS APPROXIMATELY 30 DEGREE. ABUTMENT OF PLATE NOW IS SEEN AGAINST C3.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL PROCEDURE AT C4-C6 USING ANTERIOR FIXATION PLATE SYSTEM TO TREAT THE FRACTURE. IT WAS FOUND THAT THE DIRECTIONS OF BOTH C4 SCREWS HAD BEEN CHANGED TOWARD CAUDAL ABOUT A MONTH POST OP. BONE UNION SEEM TO BE IN PROGRESS. NO COMPLICATION OR INJURY HAS BEEN REPORTED AT THIS TIME. IT WAS REPORTED THAT THE PATIENT IS GOING TO BE MONITORED CAREFULLY BECAUSE THE SCREWS BACKING OUT IS SUSPECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VENTURE ANTERIOR CERVICAL PLATE SYSTEM	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	KWQ	MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS	NA	H09J3645

Patients

Seq	Age	Sex	Outcome	Treatment
1	00057 YR			PLATE