FDA Adverse Event Malfunction Summary report: N

MAYFIELD 2000 BASE UNIT

MDR report key: 2903750 · Received January 4, 2013

Report

Report Number: 3004608878-2013-00001
Event Type: Malfunction
Date Received: January 4, 2013
Date of Event: August 20, 2012
Report Date: January 4, 2013
Manufacturer: INTEGRA LIFESCIENCES CORPORATION OH/USA
Product Code: HBL
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012, MAKES THIS COMPLAINT REPORTABLE. INITIALLY IT WAS REPORTED "DEVICES HAD BROKEN OF THE SHAFT OF THE LEVER, BOTH ACCESSORY HAS BEEN SUPPLY AROUND 2 YEARS AGO. FOR THE NEXT 2 WEEKS THE HEAD SUPPORT REMAIN IN THE HOSPITAL FOR POTENTIAL INSPECTION BY THE AUTHORITY. THE MEDICAL STAFF SAID TO THE REGULATORY MANAGER THAT THIS HAPPENED WITH THE PT BUT IF WAS NOT CLEAR." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012, MAKES THIS COMPLAINT REPORTABLE. AN A2001 WAS REPORTED TO HAVE MALFUNCTIONED. THE DESCRIPTION WAS AS FOLLOWS: IN THE REPORT IS INDICTED/WRITTEN BY THE HOSPITAL "THAT AFTER THAT INSTALL THE SUPPORT AT THE HEAD OF THE PT THE SUPPORT GET FAULT AND THIS SITUATION OBLIGED THE DOCTOR TO SUPPORT THE HEAD OF THE PT FOR FEW MINUTES WAITING THE CHANGE OF THE ACCESSORY BUT THE PT AND/OR OPERATOR DO NOT HAVE ANY DAMAGE." IN THE REPORT IS INDICATE ALSO "THAT THE BROKEN OF ANOTHER SUPPORT ONE YEARS AGO SO THERE ARE 2 PIECES OF THIS ACCESSORY INVOLVE IN THIS COMPLAINT."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
4958	MAYFIELD 2000 BASE UNIT	MAYFIELD	HBL	INTEGRA LIFESCIENCES CORPORATION OH/USA

Patients

Seq	Age	Sex	Outcome	Treatment
1