FDA Adverse Event Injury Summary report: N

INFUSE BONE GRAFT

MDR report key: 1831016 · Received September 7, 2010

Report

Report Number: 1030489-2010-01153
Event Type: Injury
Date Received: September 7, 2010
Date of Event: March 14, 2005
Report Date: August 16, 2010
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Product Code: NEK
PMA / PMN Number: P000058
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4)- LABELED YES. LITERATURE CITATION: SHIELDS ET AL. ADVERSE EFFECTS ASSOCIATED WITH HIGH-DOSE RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 USES IN ANTERIOR CERVICAL SPINE FUSION. SPINE. 2006; 31: NUMBER 5, PP 542-547. DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. WITHOUT ADD'L DEVICE INFO, A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE. WE ARE, HEREFORE, UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT COMPLICATIONS WERE OBSERVED IN PTS WHO HAD UNDERGONE ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AUGMENTED WITH HIGH-DOSE RHBMP-2. THE SURGICAL PROCEDURE WAS PERFORMED USING A MODIFIED SURGICAL TECHNIQUE. DECOMPRESSION AND DECORTICATION WERE CARRIED OUT AND THE CAGE WAS FILLED WITH RHBMP-2. ADD'L RHBMP-2 WAS ALSO PLACED LATERAL AND ANTERIOR TO THE GRAFT WITHIN THE DISC SPACE - UP TO 2.1 MG/LEVEL WAS USED. AN ANTERIOR CERVICAL PLATE WAS THEN PLACED. INTRAOPERATIVE RADIOGRAPH CONFIRMED PROPER ALIGNMENT AND FIXATION OF THE BONE GRAFT AND PLATE. FOUR PTS WHO HAD UNDERGONE A 2-LEVEL ACDF EXPERIENCED SWALLOWING/BREATHING DIFFICULTIES THAT RESULTED IN READMISSION TO THE HOSPITAL THREE DAYS POSTOPERATIVELY. NO DETAILS OR OUTCOMES WERE MENTIONED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSE BONE GRAFT	INFUSE BONE GRAFT	NEK	MEDTRONIC SOFAMOR DANEK USA, INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Hospitalization