FDA Adverse Event Malfunction Summary report: N

14MM ROTARY SCRAPER

MDR report key: 2472943 · Received February 16, 2012

Report

Report Number: 3008657535-2012-00013
Event Type: Malfunction
Date Received: February 16, 2012
Date of Event: January 18, 2012
Report Date: February 16, 2012
Manufacturer: THEKEN SPINE LLC
Product Code: MAX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO ANOMALY. A COMPLAINT SAMPLE WAS RECEIVED FOR EVALUATION. INTEGRA¿S INVESTIGATION DETERMINED THAT THE DIRECTION OF THE BREAK INDICATED THAT THE SCRAPER WAS BEING LEVERED, AS WELL AS TWISTED, TO THE POINT OF FAILURE. THE PART BROKE AT THE JUNCTION OF WHERE THE CURVED CUTTER BLADE TRANSITIONS TO THE STRAIGHT HANDLE. NO CORRECTIVE OR PREVENTIVE ACTION IS REQUIRED AT THIS TIME. INTEGRA CONSIDERS THE COMPLAINT INVESTIGATION CLOSED. FURTHER INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

Description of Event or Problem · 1

THE REPORTER STATED THAT DURING A SPINAL SURGERY PROCEDURE, THE DOCTOR WAS TOO AGGRESSIVE IN SCRAPING THE END PLATE, SO THE ROTARY SCRAPER BROKE. THE SURGEON ELECTED TO LEAVE THE END PLATE IN PLACE IN THE PT. THERE WAS NO ADVERSE OUTCOME FOR THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	14MM ROTARY SCRAPER	PLIG	MAX	THEKEN SPINE LLC		W4437

Patients

Seq	Age	Sex	Outcome	Treatment
1