SPIDER 3 LEVEL 59MM PLATE

MDR report key: 2489358 · Received March 8, 2012

Report

Report Number: 3005031160-2012-00005
Event Type: Injury
Date Received: March 8, 2012
Date of Event: October 29, 2010
Report Date: November 4, 2011
Manufacturer: X-SPINE SYSTEMS, INC.
Product Code: KWQ
PMA / PMN Number: K052292
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

PROCEDURE TYPE: ANTERIOR CERVICAL DISCECTOMY AND FUSION. DATE OF INITIAL SURGERY: (B)(6) 2009. DATE OF SECOND SURGERY: (B)(6) 2010. ACCORDING TO THE REPORTER: THE INITIAL SURGERY WAS PERFORMED ON OR ABOUT (B)(6) 2009. A RE-OPERATION WAS PERFORMED ON OR ABOUT (B)(6) 2010 TO REMOVE THE IMPLANTS DUE TO AN ALLEGED FAILURE. DURING THE RE-OPERATION, A NEW PLATE AND SCREWS WERE IMPLANTED. A SECOND ALLEGED FAILURE OCCURRED ON OR ABOUT (B)(6) 2011. THE SECOND SYS SCREWS AND PLATE WERE EXPLANTED. INITIAL INFO RECEIVED 11/4/2011 ALLEGED X-SPINE SYSTEMS, INC DEVICES 72521 AND 83168 FAILED. TWO COMPLAINTS WERE OPENED BECAUSE THERE WERE TWO ALLEGED FAILURES. PLEASE SEE MDR #3005031160-2012-00006 AS CROSS-REFERENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPIDER 3 LEVEL 59MM PLATE	ANTERIOR CERVICAL PLATING SYSTEM	KWQ	X-SPINE SYSTEMS, INC.	N60000116	72521

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other