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

Model Number A2114

Device Problem Device Slipped (1584)

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

Event Date 12/01/2022

Event Type  malfunction  

Event Description

Mayfield skull clamp could not maintain pressure and slipped.Caused laceration to scalp and bleeding and necessitating wound closure.

• Brand Name: MAYFIELD
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 16077269
• MDR Text Key: 306501078
• Report Number: 16077269
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: A2114
• Device Catalogue Number: A2114
• 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: 12/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28105 DA