FDA Adverse Event Injury Summary report: N

DEPUY MITEK ARCS ANCHORS

MDR report key: 1040006 · Received May 6, 2008

Report

Report Number: 1221934-2008-00275
Event Type: Injury
Date Received: May 6, 2008
Date of Event: April 16, 2008
Report Date: May 6, 2008
Manufacturer: DEPUY MITEK
Product Code: MBI
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP CONTACT WITH FACILITY REVEALED THE AREA WAS CULTURED, HOWEVER, THE RESULTS WERE NOT GIVEN. THE PATIENT WAS TREATED WITH ANTIBIOTICS, NO OTHER INFO WAS AVAILABLE AT THIS TIME. A BATCH RECORD REVIEW HAS BEEN CONTACTED TO DETERMINE IF THERE IS ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT. A REVIEW OF THE DEPUY MITEK COMPLAINTS DID NOT REVEAL ANY OTHER COMPLAINTS FOR THIS LOT NUMBER. ALTHOUGH, IT IS BEING REPORTED THE PT IS DOING FINE, WE DO NOT KNOW WHAT IMPACT, IF ANY, THIS WILL HAVE ON THE PATIENT IN THE FUTURE AND BECAUSE OF THIS UNCERTAINTY THAT THIS REPORT IS BEING FILED TO DOCUMENT THIS EVENT. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS.

Description of Event or Problem · 1

THE CALLER IS REPORTING A PT RETURNED TO THE SURGEON WITH AN INFECTION. THE ORIGINAL SURGERY WAS IN 2008, THE PT RETURNED AT ABOUT ONE MONTH LATER. NO OTHER INFO HAS BEEN PROVIDED AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DEPUY MITEK ARCS ANCHORS	SOFT TISSUE FIXATION DEVICES	MBI	DEPUY MITEK		3089036

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK