FDA Adverse Event Injury Summary report: N

RESOLVE HALO PINS

MDR report key: 4961219 · Received July 28, 2015

Report

Report Number: 1836248-2015-00003
Event Type: Injury
Date Received: July 28, 2015
Date of Event: June 16, 2015
Report Date: July 27, 2015
Manufacturer: OSSUR AMERICAS
Product Code: ISY
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

NO PRODUCT MALFUNCTION IDENTIFIED - UNABLE TO ESTABLISH CORRELATION BETWEEN PATIENT FALL AND PRODUCT FUNCTION. AFTER THE PATIENT FALL, THE PRODUCT WAS INTACT AND PINS WERE REPOSITIONED, NO FURTHER INCIDENTS IDENTIFIED. ACCORDING TO THE (B)(6), THE HALO WAS INTACT WHEN THE PATIENT VISITED THEIR FACILITY. THE PIN PENETRATION WAS A RESULT OF THE PATIENT STUMBLING AND FALLING ONTO THE HALO.

Description of Event or Problem · 1

(B)(6) UNDERWENT CRANIAL SURGERY AT (B)(6) HOSPITAL UNDER THE CARE OF SURGEON DR. (B)(6). SHE CLAIMS THE DAY AFTER SURGERY WHILE LYING IN BED ONE OF THE PINS ON THE HALO DEVICE SLIPPED CAUSING THE HALO TO SHIFT. SHE WAS ABLE TO GRAB THE HALO AND KEEP IT STABLE WHILE THE NURSE REAPPLIED THE HALO BEDSIDE. SINCE SHE HAS PREVIOUSLY WORN A HALO AND IS FAMILIAR WITH IT, SHE CLAIMS IT WAS NOT APPLIED WITH THE PROPER TORQUE. AFTER SHE WAS RELEASED, SHE WENT TO (B)(6) UNIVERSITY AND ASKED THEM TO REAPPLY IT FOR HER SINCE SHE WAS MORE CONFIDENT IN THEIR APPLICATION. PATIENT FELL ON (B)(6) 2015 DUE TO A MISHAP AND HIT HER HEAD WHILE WEARING THE HALO. THIS CAUSED BLEEDING AT THE RIGHT FRONT PIN. SHE WAS TRANSPORTED TO THE ER; THE ER WAS UNABLE TO ADJUST THE HALO, SO SHE WAS AGAIN TRANSPORTED TO (B)(6) ORTHOPEDICS FOR PROPER ADJUSTMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
488071	RESOLVE HALO PINS	COMPONENT, TRACTION, INVASIVE	ISY	OSSUR AMERICAS	505400C

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other