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

Model Number A1059

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 05/09/2022

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that there was an issue during an unspecified case during positioning a patient in the mayfield modified skull clamp (a1059).Additional information was received stating that patient was clamped in the mayfield, and at the end of the procedure (fixation on the operating table), the mayfield opened (torque screw part).The patient suffered a laceration which had to be sutured (approx.6 cm).The mayfield was immediately removed from service.No increase in surgery time was reported.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.The mayfield skull clamp (a1059) was returned for evaluation: failure analysis - evaluation found that there was play in the clamp and it required replacement of worn components from routine use and wear.Additionally, improper or suboptimal positioning of the skull clamp on the patient can contribute to slippage and movement of the patient's head.Root cause - complaint confirmed.Evaluation found that there was play in the clamp and it required replacement of worn components from routine use and wear.Additionally, improper or suboptimal positioning of the skull clamp on the patient can contribute to slippage and movement of the patient's head.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.

Event Description

N/a.

Manufacturer Narrative

This mdr is being submitted for correction of an error which was submitted in follow up mdr #1."type of reportable event" should have read "serious injury.".

• 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: 14580803
• MDR Text Key: 293275130
• Report Number: 3004608878-2022-00114
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Male