FDA Adverse Event Malfunction Summary report: N

REBOUND HRD

MDR report key: 2105093 · Received May 16, 2011

Report

Report Number: 3005770977-2011-00001
Event Type: Malfunction
Date Received: May 16, 2011
Report Date: May 16, 2011
Manufacturer: MINNESOTA MEDICAL DEVELOPMENT, INC.
Product Code: FTL
PMA / PMN Number: K083467
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION IS CONTINUING. DEVICE HISTORY RECORDS HAVE BEEN EVALUATED AND DO NOT REVEAL ANY COMPONENT DEFICIENCIES. OF THE APPROXIMATELY 4000 POLYPROPYLENE AND APPROXIMATELY 1000 TEFLON IMPLANTS TO DATE THESE ARE THE FIRST INSTANCES OF SEPARATION REPORTED TO THE MFR. ADDITIONAL 510K#'S K083467, K080393, K083467. ADDITIONAL SURGERY DATE: (B)(6) 2010. ADDITIONAL FOLLOW UP X-RAY DATE: (B)(6) 2011. ADDITIONAL MODEL#: RB-OVL-XL-PTFE, RB-HYB-L-PP, RB-OVL-M-PTFE. ADDITIONAL MODEL NAME: HRD V OVAL EXTRA LARGE, HRD HYBRID LARGE, HRD V OVAL MEDIUM. ADDITIONAL DEVICE MFR DATE: 01-2009, 09-2009, 01-2009. ADDITIONAL STERILE LOT NUMBER: 080159, 090085, 080157. ADDITIONAL EXPIRATION DATE: 06-2010, 08-2012, 06-2010.

Description of Event or Problem · 1

DEVICES CONSIST OF A POLYPROPYLENE OR TEFLON MESH WITH THE MESH ATTACHED TO A .046 INCH DIAMETER NITINOL CABLE THAT SURROUNDS THE MESH AND IS DESIGNED TO KEEP THE MESH TAUT. X-RAYS APPROX 1 YEAR AFTER IMPLANT AS PART OF PREPARATION OF AN AUTHORITATIVE JOURNAL ARTICLE HAVE JUST SHOWN THAT A SLIGHT SEPARATION HAS OCCURRED IN ONE PLACE ON THE NITINOL CABLE. THIS HAS OCCURRED IN FOUR IMPLANTS. THE PRODUCT APPEARS TO CONTINUE TO BE EFFICACIOUS AND THE PTS HAVE NO COMPLAINTS, COMPLICATIONS, OR SYMPTOMS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	REBOUND HRD	HERNIA REPAIR DEVICE	FTL	MINNESOTA MEDICAL DEVELOPMENT, INC.	RB-OVL-L-PTFE	090087

Patients

Seq	Age	Sex	Outcome	Treatment
1