FDA Adverse Event Injury Summary report: N

INFUSE BONE GRAFT

MDR report key: 2860924 · Received December 6, 2012

Report

Report Number: 1030489-2012-02625
Event Type: Injury
Date Received: December 6, 2012
Report Date: August 14, 2017
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: NEK
PMA / PMN Number: P000058
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, 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

(B)(4).

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 SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SUR GERY. NO ADDITIONAL INFORMATION WAS REPORTED.

Description of Event or Problem · 1

REPORTEDLY THE PATIENT DEVELOPED "SERIOUS INJURY INCLUDING PAIN AND NERVE INJURIES."

Description of Event or Problem · 1

IT WAS REPORTED THAT ON: (B)(6) 2005: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE AT L5-S1 AND UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION(ALIF) AT L5/S1 IN WHICH RH-BMP2/ACS WAS USED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSE BONE GRAFT	FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET	NEK	MEDTRONIC SOFAMOR DANEK USA, INC	NA	M114007AAC

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R