FDA Adverse Event Injury Summary report: N

SCREWS & WASHERS, 14MM

MDR report key: 2092553 · Received May 3, 2011

Report

Report Number: 1221934-2011-00185
Event Type: Injury
Date Received: May 3, 2011
Date of Event: March 9, 2011
Report Date: April 14, 2011
Manufacturer: DEPUY MITEK
Product Code: MBI
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A F/U REPORT.

Description of Event or Problem · 1

THE PT UNDERWENT A SUCCESSFUL ARTHROSCOPIC ACL REPAIR ON (B)(6) 2011: APPROX 5 WEEKS POST-OPERATIVELY, THE PT PRESENTED WITH A "STAPH" INFECTION. SEVERAL MITEK INSTRUMENTS AND DEVICES TO FIXATE AN RTI ALLOGRAFT WERE USED IN THE PROCEDURE: FIXATION DEVICES HAVE BEEN IDENTIFIED, HOWEVER, NO INSTRUMENTATION INFO HAS BEEN SUPPLIED. AT THIS POINT IN TIME, THIS IS ALL OF THE INFO THAT HAS BEEN MADE AVAILABLE TO MITEK; THERE ARE QUESTIONS OUT TO THE FACILITY CONTACT FOR FURTHER DETAIL AND CLARITY. ALSO SEE ASSOCIATED MDRS: 1221934-2011-00184, 00186, 00187, 00188, 00189, AND 00190.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SCREWS & WASHERS, 14MM	SOFT TISSUE FIXATION DEVICE	MBI	DEPUY MITEK	221114	0908584

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention