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

Catalog Number XXX-MAYFIELD SKULL CLAMP

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

Mdr report# mw5146670 was received with the following information: "an 8cm head laceration caused by three point mayfield device originally positioned by surgical team.Laceration on left side of head, sutured at end of case using 3-0 biosin.Attending notified, charge nurse notified.Patient head slipped lower during case.Resident asked to secure head fellow.".

Manufacturer Narrative

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

Manufacturer Narrative

The mayfield skull clamp was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, the device history record (dhr) could not be reviewed, and the definite root cause cannot be identified.Based on the reported complaint, probable root cause is improper or suboptimal placement of the skull clamp on the patient.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: UNKNOWN MAYFIELD SKULL CLAMP
• Type of Device: SKULLCLAMPS 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: 18152550
• MDR Text Key: 328317489
• Report Number: 3004608878-2023-00209
• 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: Other,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

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 Catalogue Number: XXX-MAYFIELD SKULL CLAMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/12/2024
• 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