FDA Adverse Event Injury Summary report: N

INFUSE BONE GRAFT

MDR report key: 3171087 · Received June 14, 2013

Report

Report Number: 1030489-2013-02296
Event Type: Injury
Date Received: June 14, 2013
Report Date: November 28, 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.

Additional Manufacturer Narrative · 1

A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

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 BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR L4-L5 FUSION WHERE RHBMP-2 WAS MIXED WITH LOCAL BONE VOID FILLER, AND IMPLANTED VIA A POSTERIOR APPROACH. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

Description of Event or Problem · 1

IT WAS REPORTED THAT, ON (B)(6) 2007, PER IMPLANT LOG PATIENT UNDERWENT SPINAL FUSION (TLIF L4-5) SURGERY IN WHICH RHBMP-2/ACS WAS USED. PRE-OP DIAGNOSIS: SPINAL STENOSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
270298	INFUSE BONE GRAFT	FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET	NEK	MEDTRONIC SOFAMOR DANEK USA, INC	NA	M110606AAJ

Patients

Seq	Age	Sex	Outcome	Treatment
1	00056 YR		Required Intervention