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

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 06/04/2017

Event Type  malfunction  

Event Description

Patient in prone position in a mayfield head holder.At end of the procedure, the patient's left side of head pin site had 2 1/2 cm laceration from pin.The laceration was closed by staples.

• Brand Name: MAYFIELD HEAD HOLDER
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 6642752
• MDR Text Key: 77619270
• Report Number: 6642752
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO. LACERATION FROM MAYFIELD PIN.; NOT APPLICABLE.
• Patient Outcome(s): Other
• Patient Age: 74 YR