FDA Adverse Event Injury Summary report: N

INFUSE BONE GRAFT

MDR report key: 1020026 · Received March 27, 2008

Report

Report Number: 1030489-2008-00154
Event Type: Injury
Date Received: March 27, 2008
Date of Event: August 21, 2007
Report Date: February 29, 2008
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Product Code: MPW
PMA / PMN Number: P000054
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO TREAT A SEQUENTIAL RIGHT HUMERAL MALUNION/NON-UNION DURING WHICH RHBMP-2/ACS WAS IMPLANTED AS WELL AS A STAINLESS STEEL SYNTHES PROXIMAL HUMERUS LOCKING PLATE. AT AN UNKNOWN TIME POST-OP, THE PATIENT DEVELOPED LOCALIZED SWELLING, AND INCISIONAL DEHISCENCE. A SURGICAL INTERVENTION WAS PERFORMED TWO AND HALF WEEKS POST-OP TO IRRIGATE AND DEBRIDE THE SITE. CULTURES TAKEN DURING THE I & D ULTIMATELY GREW STAPH, AND ENTEROCOCCUS (SPECIES UNSPECIFIED). THE PATIENT IS REPORTED DOING WELL. THE LOCALIZED SWELLING HAS RESOLVED, THE INCISION HAS HEALED, AND THE HUMERAL MALUNION AND NON-UNION HAVE RESOLVED. THE HARDWARE WAS REPORTEDLY REMOVED SEVEN MONTHS POST-OP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSE BONE GRAFT	INFUSE BONE GRAFT	MPW	MEDTRONIC SOFAMOR DANEK USA, INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Required Intervention	STAINLESS STEEL SYNTHES PROXIMAL HUMERUS LOCKING\| PLATE WAS IMPLANTED\| EXPLANTED