MAUDE Adverse Event Report: OSSUR AMERICAS RESOLVE HALO PINS; COMPONENT, TRACTION, INVASIVE

Model Number 505400C

Device Problem Positioning Problem (3009)

Patient Problems Fall (1848); Hemorrhage/Bleeding (1888)

Event Date 06/16/2015

Event Type  Injury  

Event Description

(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.

Manufacturer Narrative

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.

• Brand Name: RESOLVE HALO PINS
• Type of Device: COMPONENT, TRACTION, INVASIVE
• Manufacturer (Section D): OSSUR AMERICAS; albion MI
• Manufacturer Contact: karen montes ; 27051 towne centre; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 4961219
• MDR Text Key: 6255987
• Report Number: 1836248-2015-00003
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 505400C
• Device Catalogue Number: 505400C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 73