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

Catalog Number A1059

Device Problem Failure to Cycle (1142)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

A facility reported that during a neuro procedure, the pressure gauge of the mayfield modified skull clamp (a1059), would only turn to 40lbs and not 60-80lbs of pressure.Consequently, the patient slipped out of the pins before surgery, prompting re-pinning using an alternative clamp.Additional information received as follows: 1.Please describe the patient's injury.Patient fell out of pins prior to surgery when 40 pounds of pressure was applied.2.Please provide details surrounding the injury.Patient was pinned prior to surgery and fell out immediately after- patient was then re-pinned with a different clamp.4.Please provide patient gender, ethnicity, and race.Will need to get this information early next week.6.Was revision/medical intervention required? if yes, what revision/medical intervention was performed? re-pinned using a different head clamp.7.Was there a delay in surgery due to product problem? if yes, how long? yes, to re-pin.This took around 10 minutes.8.Please provide patient outcome.No injuries- no lacerations.

Manufacturer Narrative

The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.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 slippage.When the clamp is properly positioned and put under pressure, it would not lose pressure.Unrelated to the complaint issue, the lock had rotational and lateral movement and a residue buildup was present.To resolve all issues, the unit was machined to have heli-coils added to large starburst threads, new components were added to replace worn internal parts, and general maintenance and cleaning were performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.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: 18284711
• MDR Text Key: 330122032
• Report Number: 3004608878-2023-00224
• Device Sequence Number: 1
• Product Code: HBL
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• 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