OP-1 PUTTY (OSTEOGENIC PROTEIN 1)

Report

Report Number: 1224732-2014-00001
Event Type: Injury
Date Received: October 6, 2014
Date of Event: January 7, 2009
Report Date: September 12, 2014
Manufacturer: OLYMPUS BIOTECH CORPORATION
Product Code: MQV
PMA / PMN Number: H020008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THIS PRODUCT IS NO LONGER MARKETED AND THE OLYMPUS BIOTECH DIVISION HAS CEASED ALL OPERATIONS. A WITHDRAWAL REQUEST FOR THE HDE (B)(4) WAS MADE IN (B)(6) 2014 AND FDA ACKNOWLEDGMENT RECEIPT WAS CONFIRMED IN A LETTER DATED (B)(6) 2014.

Description of Event or Problem · 1

PATIENT CALLED PRODUCT COMPLAINTS LINE FOR OLYMPUS BIOTECH OP-1 PUTTY AND REPORTED ONGOING MEDICAL PROBLEMS FOLLOWING A SURGERY ON HER BACK. PATIENT INDICATES OP-1 PUTTY WAS USED DURING THE PROCEDURE THAT WAS PERFORMED ON (B)(6) 2009. PATIENT INDICATED A NEW PAIN/DISCOMFORT IN HER LEG DID NOT SUBSIDE AFTER SURGERY AND CONTINUES TO HAVE THE SAME PROBLEMS. PATIENT VISITED A DIFFERENT CLINIC FOR FOLLOW-UP WHERE A PHYSICIAN ORDERED AN MRI BE TAKEN OF THE PATIENT'S BACK WHERE THE SURGERY WAS PERFORMED. THAT VISIT AND MRI SCAN TOOK PLACE ON (B)(6) 2012. PATIENT INDICATES THE PHYSICIAN TOLD HER THAT THE OP-1 PUTTY HAD "DROPPED TO THE BOTTOM OF THE PATIENT'S BACK" AND HAD BROKEN UP TO A POINT IN WHICH IT WAS INOPERABLE. PATIENT ATTRIBUTES THE FOLLOWING COMPLICATIONS AS A RESULT OF THE SURGERY WHERE OP-1 PUTTY WAS USED: SEVERE DIFFICULTY WALKING OR MOVING, GASTRIC PROBLEMS, BLADDER/BOWEL COMPLICATIONS, NERVE DAMAGE IN LEGS, SCAR TISSUE AS INDICATED BY LATER MRI.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
622217	OP-1 PUTTY (OSTEOGENIC PROTEIN 1)	FILLER, BONE VOID, CALCIUM COMPOUND	MQV	OLYMPUS BIOTECH CORPORATION	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Disability