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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2021

Event Type  malfunction  

Event Description

Resident was placing the patient in the mayfield head holder, while attending was present.The head holder would not hold beyond 40 lbs.Of pressure.The head holder was removed.The pin site was inspected for fracture into the bone.Given the fact that the head holder could not hold the pressure, patient taken for a ct scan while she was intubated.Patient then came back to operating room, extubated and went to the recovery room.Surgery was aborted.

• Brand Name: MAYFIELD SKULL CLAMP
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 12452441
• MDR Text Key: 270871661
• Report Number: 12452441
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 08/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2021
• 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: 25185 DA