MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A1059

Device Problem Mechanical Problem (1384)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Event Description

A facility reported that the mayfield modified skull clamp (a1059) only allowed 40 pounds of pressure, making it unsuitable for surgery.They pulled new skull clamp and created additional pin holes.

Manufacturer Narrative

Mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.Service & repair (s&r) could not duplicate the reported issue.When the clamp is properly positioned and put under pressure, it did not slip or lose pressure.Further, the unit was sent to quality engineering for further investigation due to an injury to the patient (the injury was additional pin holes).Quality engineering confirm the findings of the s&r team and noted no additional device deficiencies.Unrelated to the reported complaint, new components were added to replace worn internal parts, and general maintenance and cleaning were performed.Root cause - the complaint is not confirmed.Probable root cause is improper or suboptimal placement of the skull clamp on the patient.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18240266
• MDR Text Key: 329398518
• Report Number: 3004608878-2023-00219
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1