MAUDE Adverse Event Report: INTEGRA BURLINGTON MA, INC. HEAD RING DRIVE EXTEND/SHORT

Catalog Number HRDXS

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

The headring drive extensions were not braised/soldered completely through the two layers of metal, only on the surround of the metal, which meant than when screwed into the patients head, they bent.Incomplete brazing causing the metal plates to separate.The four drive post subsequently bent.The problem occurred during intubation head ring fixation for a stereotactic radiosurgery case.There was a 30-40 minute surgical delay.There was patient contact.There was no patient injury.Additional information was requested and the following was received (b)(6) 2014: the problem occurred during a stereotactic radiosurgery on an adult female who required the procedure due to arteriovenous malformation of cerebral vessels on (b)(6) 2014.The surgical delay reported was caused by the bending of the product when it was screwed into the patient's head.The patient was awake during the procedure.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: HEAD RING DRIVE EXTEND/SHORT
• Type of Device: NA
• Manufacturer (Section D): INTEGRA BURLINGTON MA, INC.; burlington MA 01803
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr.; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4260816
• MDR Text Key: 5050821
• Report Number: 1222895-2014-00031
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K944463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HRDXS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1