FDA Adverse Event Other Summary report: N

SUBTALAR MBA IMPLANT 14MM

MDR report key: 2222539 · Received August 11, 2011

Report

Report Number: 3004608878-2011-00113
Event Type: Other
Date Received: August 11, 2011
Report Date: August 11, 2011
Manufacturer: INTEGRA, CINCINNATI
Product Code: MJW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

Description of Event or Problem · 1

THE REPORTER STATED THAT THE PATIENT WAS ANESTHETIZED FOR A SURGICAL PROCEDURE TO IMPLANT THE SUBTALAR MBA SYSTEM (INDICATED FOR USE IN TREATMENT OF THE HYPERPRONATED FOOT AND STABILIZATION OF THE SUBTALAR JOINT). THE SURGEON REQUESTED A SIZE 14 MM IMPLANT. THE PRODUCTS AVAILABLE IN THE HOSPITAL INVENTORY HAD AN EXPIRATION DATE OF JUNE 30, 2011. THE SURGERY WAS DONE ON (B)(6) 2011. THE USER FACILITY ELECTED TO REPROCESS THE PRODUCTS IN THE HOSPITAL AUTOCLAVE (WITH BIOLOGICAL INDICATORS) IN ACCORDANCE WITH JOINT COMMISSION PROTOCOLS. THERE HAS BEEN NO ADVERSE OUTCOME FOR THE PATIENT TO DATE. THE PRODUCTS HAD BEEN PART OF THE HOSPITAL'S OWN INVENTORY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SUBTALAR MBA IMPLANT 14MM	NA	MJW	INTEGRA, CINCINNATI		7603-14-10321

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other