FDA Adverse Event Injury Summary report: N

AXIALIF 2L

MDR report key: 2853049 · Received August 24, 2012

Report

Report Number: 3004578806-2012-00006
Event Type: Injury
Date Received: August 24, 2012
Report Date: August 15, 2012
Manufacturer: TRANS1
Product Code: KWQ
PMA / PMN Number: K073643
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE COULD NOT BE EVALUATED AS IT WAS NOT RETURNED TO MANUFACTURER, AND NO INFORMATION ABOUT THE DEVICE USED WAS AVAILABLE. THIS EVENT WAS NOT REPORTED TO MANUFACTURER, BUT WAS DISCOVERED IN JOURNAL PUBLICATION BY MANUFACTURER. THIS EVENT CANNOT BE CONFIRMED, AND NO DETAILS REGARDING THE DEVICE USED ARE AVAILABLE. THE DEVICE REPORTEDLY USED IS AN EARLY VERSION OF THE DEVICE THAT WAS NEVER DISTRIBUTED IN THE US AND IS NO LONGER AVAILABLE. THE MANUFACTURER IS UNABLE TO CONFIRM THE OCCURRENCE OF THE BOWEL INJURY REPORTED IN THE REFERENCED PAPER, BUT AS A DILIGENCE EFFORT IS REPORTING THIS ADVERSE EVENT TO FDA.

Description of Event or Problem · 1

A PAPER WAS PUBLISHED THAT REPORTED A BOWEL INJURY THAT WAS NOT REPORTED TO TRANS1. THE PAPER WAS DISCOVERED BY QUALITY ON (B)(4) 2012, AND HAS THE FOLLOWING CITATION: MARCHI L, OLIVERIA L, COUTINHO E, PIMENTA L: RESULTS AND COMPLICATIONS AFTER 2-LEVEL AXIAL LUMBAR INTERBODY FUSION WITH A MINIMUM 2-YEAR FOLLOW-UP. JOURNAL OF NEUROSURGERY: SPINE. ONE 2012 JULY 17; EPUB AHEAD OF PRINT, DOI 10.3171/2012.6. SPINE11915. TRANS1 WAS UNAWARE OF THE OUTCOMES REPORTED IN THIS PAPER UNTIL THE PAPER WAS PUBLISHED. THIS PAPER IS TRANS1 IS UNABLE TO CONFIRM THAT VALIDITY OF THIS BOWEL INJURY REPORT, BUT FEELS IT NECESSARY TO REPORT THIS EVENT AS A COMPLICATION TO FDA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AXIALIF 2L	ANTERIOR SPINAL FIXATION	KWQ	TRANS1

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization