FDA Adverse Event Injury Summary report: N

INFUSE BONE GRAFT

MDR report key: 3190234 · Received June 26, 2013

Report

Report Number: 1030489-2013-02518
Event Type: Injury
Date Received: June 26, 2013
Report Date: September 26, 2016
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: NEK
PMA / PMN Number: P000058
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

(B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L4-L5 FUSION INVOLVING RHBMP-2/ACS. SURGEON UTILIZED A POSTERIOR APPROACH, USED A CAGE, AND MIXED RHBMP-2/ACS WITH AUTOGRAFT. THE PATIENT WAS DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. AS A RESULT, PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT. PATIENT HAS NEVER RECOVERED FROM HIS SURGERY INVOLVING RHBMP-2/ACS, AND HE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291095	INFUSE BONE GRAFT	FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET	NEK	MEDTRONIC SOFAMOR DANEK USA, INC	NA	M110604AAH

Patients

Seq	Age	Sex	Outcome	Treatment
1	00049 YR		Other