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

Model Number A1059

Device Problem Mechanics Altered (2984)

Patient Problem Laceration(s) (1946)

Event Date 03/20/2023

Event Type  Injury  

Event Description

A facility reported that during an unspecified procedure, the patient's head became dislodged from the two anterior pins of the mayfield modified skull clamp (a1059).The surgeon unscrubbed and assessed the resulting positioning quickly assessed the integrity of the patient's head of what could be visualized beneath the draping, removed the loose pins, and instructed the nursing staff to pad the posterior aspect of the head clamp.After consulting with another surgeon, the decision was made to continue with the procedure with the head resting on the pad and the mayfield head clamp.Following the procedure, the surgeon reassessed the patient's skin integrity, and a minor wound was observed.The surgeon cleaned the site, sutured where required, and closed with steri-strips.There was a 30 minute delay reported.

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

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.The repairs team could not duplicate slippage due to not receiving the ratchet extension.The unit had slight movement in the lock, but when properly positioned and put under pressure, it would not move.Further investigation by quality engineering confirms the findings of the service and repair report, no additional issues observed.Unrelated to the reported complaint, new components were added to replace worn internal parts, and general maintenance and cleaning were performed.Root cause - complaint not confirmed via inspection of the unit.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.

Event Description

N/a.

• 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: 16738238
• MDR Text Key: 313303122
• Report Number: 3004608878-2023-00060
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2020
• 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