MAUDE Adverse Event Report: INTEGRA INTEGRA RADIOLUCENT HEAD HOLDER A2010; HORSESHOE

Model Number A2079 XR2

Device Problems Component Falling (1105); Unintended Head Motion (1284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2016

Event Type  Injury  

Event Description

At conclusion of this procedure, during the placement of the final screw, the mayfield radiolucent head holder underwent a failure and the head holder unfortunately dropped away from the patient secondary to shearing of the radiolucent pin.The patient's head was immediately grabbed through the drapes and supported until the head of the bed could be affixed beneath the drapes.

• Brand Name: INTEGRA RADIOLUCENT HEAD HOLDER A2010
• Type of Device: HORSESHOE
• Manufacturer (Section D): INTEGRA; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 6282798
• MDR Text Key: 66029169
• Report Number: MW5067502
• Device Sequence Number: 1
• Product Code: HBL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2079 XR2
• Device Catalogue Number: A2010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 111