FDA Adverse Event Injury Summary report: N

INFUSE BONE GRAFT

MDR report key: 1841299 · Received September 13, 2010

Report

Report Number: 1030489-2010-01182
Event Type: Injury
Date Received: September 13, 2010
Date of Event: February 17, 2006
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: IA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). LITERATURE CITATION: SMUCKER, ET AL. INCREASED SWELLING COMPLICATIONS ASSOCIATED WITH OFF-LABEL USAGE OF RHBMP-2 IN THE ANTERIOR CERVICAL SPINE. SPINE. 2006; VOLUME 31, NUMBER 24: PP 2813-2819. A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED WITHOUT ADDITIONAL DEVICE INFORMATION. WITHOUT RETURN OF THE DEVICE OR ASSOCIATED RECORDS, IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT.

Description of Event or Problem · 1

SWELLING COMPLICATIONS WERE REPORTED IN A RETROSPECTIVE STUDY OF PTS WHO UNDERWENT ANTERIOR CERVICAL FUSION USING RHBMP-2. FUSION WAS PERFORMED THROUGH A STANDARD SURGICAL APPROACH USING RHBMP-2 AT A CONCENTRATION OF 1.5MG/ML, HOWEVER THE ACTUAL DOSE OF RHBMP-2 APPLIED COULD NOT BE DETERMINED. IT IS NOT KNOWN IF RHBMP-2 IN THIS PT WAS PLACED IN A CORTICAL RING ALLOGRAFT OR INTERBODY SPACER, AND/OR AROUND THE GRAFT ITSELF IN THE DISC SPACE. THE SWELLING COMPLICATIONS OCCURRED IN A DELAYED FASHION AFTER A SEEMINGLY UNEVENTFUL SURGERY, EXTUBATION, AND INITIAL POSTOPERATIVE COURSE. THE PT, WHO UNDERWENT INITIAL 3-LEVEL ANTERIOR CERVICAL FUSION, EXPERIENCED SEVERE DYSPHAGIA THAT RESULTED IN A DELAYED HOSPITAL DISCHARGE. 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