MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Model Number A1059

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Date 10/06/2016

Event Type  malfunction  

Event Description

Patient was placed in "new model" mayfield head positioner in prone position on chest rolls.Headpiece was secured to mayfield base on or table.Patient body was secured and positioned.After positioning was completed, it was noted that one of the head pins had lacerated the patient scalp.

• Brand Name: MAYFIELD
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 4900 charlemar dr.,; building a; cincinnati OH 45227
• MDR Report Key: 6205182
• MDR Text Key: 63303647
• Report Number: 6205182
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2016,11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 114