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

Model Number A2114

Device Problems Pressure Problem (3012); Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 12/01/2022

Event Type  Injury  

Event Description

Mayfield head clamp not able to maintain pressure, slipped with head in pins.Caused laceration to scalp, increased bleeding, additional need for wound closure.

• Brand Name: MAYFIELD SKULL CLAMP
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 15977327
• MDR Text Key: 305525862
• Report Number: MW5113765
• 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: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A2114
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Male