FDA Adverse Event Injury Summary report: N

UNK LATARJET SCREW

MDR report key: 6639394 · Received June 14, 2017

Report

Report Number: 1221934-2017-10288
Event Type: Injury
Date Received: June 14, 2017
Report Date: May 15, 2017
Manufacturer: DEPUY MITEK
Product Code: HWC
PMA / PMN Number: UNKNOWN
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

MITEK MEDICAL SAFETY DEPARTMENT DISCOVERED THIS PUBLISHED WHITE PAPER DETAILING A HISTORICAL EVENT IN WHICH SOME MITEK DEVICES WERE IMPLICATED. IT CANNOT BE CONFIRMED THAT THIS ISSUE HAD BEEN PREVIOUSLY REPORTED TO MITEK, SO AN ADVERSE EVENT REPORT IS BEING FILED TO DOCUMENT THE EXPERIENCE DESCRIBED IN THE ARTICLE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE AUTHOR REGARDING EACH OF THE 8 PROCEDURES AND PATIENTS CONDITION, BUT NONE HAS BEEN RECEIVED. THEREFORE, A CONSOLIDATED REPORTED FOR ALL 8 PATIENTS IS BEING FILED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS FILE WILL BE RE-OPENED AND ADDITIONAL DETAILS WILL BE PROVIDED. MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI- UNAVAILABLE.

Description of Event or Problem · 1

THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: THE ARTHROSCOPIC LATARJET PROCEDURE FOR ANTERIOR SHOULDER INSTABILITY: 5 YEAR MINIMUM FOLLOW UP. AUTHORS: DUMONT GUILLAUME D., FOGERTY SIMON, ROSSO CLAUDIO, AND LAFOSSE LAURENT THE AMERICAN JOURNAL OF SPORTS MEDICINE AM J SPORTS MED 2014 42:2560, DOI: 10.1177/0363546514544682. (B)(6). N=1 EIGHT PATIENTS HAD REVISION SURGERY FOR HARDWARE REMOVAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
421144	UNK LATARJET SCREW	MITEK ANCHOR IMPLANTS	HWC	DEPUY MITEK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other