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

Model Number 431A1030

Device Problem Positioning Problem (3009)

Patient Problem Laceration(s) (1946)

Event Date 02/22/2019

Event Type  Injury  

Event Description

Patient having a suboccipital craniectomy for cyst fenestration.Post mayfield head positioning device placement, while positioning patient prone, the patient's head moved causing left temporal pin site laceration.The laceration is slightly bigger than one inch and required cleansing and sutures.

• 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: 8435639
• MDR Text Key: 139305168
• Report Number: 8435639
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2019,02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 431A1030
• Device Lot Number: A-1059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 16425 DA
• Patient Weight: 97