FDA Adverse Event Injury Summary report: N

MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

MDR report key: 3885106 · Received June 19, 2014

Report

Report Number: 3006179046-2014-00014
Event Type: Injury
Date Received: June 19, 2014
Report Date: May 19, 2014
Manufacturer: ELLIPSE TECHNOLOGIES, INC.
Product Code: PGN
PMA / PMN Number: K140178
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INFORMATION WITH REGARD TO THE PATIENT'S GENDER, AGE, AND WEIGHT WERE NOT PROVIDED. THE ALLEGED BROKEN MAGEC ROD WAS REMOVED AND THE PATIENT WAS IMPLANTED WITH A NEW MAGEC ROD, WITHOUT INCIDENT. TO DATE, THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, NO EVALUATION CAN BE CONDUCTED. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS AND THAT THE DEVICE WAS RELEASED WITHIN SPECIFICATIONS. THIS IS NOT AN UNUSUAL EVENT FOR GROWING ROD PATIENTS. IN THE LITERATURE, GROWING RODS HAVE BEEN REPORTED TO BREAK IN APPROXIMATELY 25% OF CASES (BESS S, ET.AL., "COMPLICATIONS OF GROWING-ROD TREATMENT FOR EARLY ONSET SCOLIOSIS: ANALYSIS OF ONE HUNDRED AND FORTY PATIENTS", J BONE JOINT SURG AM. 2010; 92: 1-11.).

Description of Event or Problem · 1

A SURGEON ALLEGED THAT A PATIENT'S MAGEC ROD BROKE. THE DEVICE HAD BEEN IMPLANTED FOR OVER TWO (2) YEARS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
361346	MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	GROWING ROD SYSTEM- MAGNETIC ACTUATION	PGN	ELLIPSE TECHNOLOGIES, INC.	RA002-5555SL	120215-001

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| O