MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD SWIVEL HORSESHOE HEADREST; N/A

Catalog Number A1012

Device Problem Device Slipped (1584)

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

Event Type  malfunction  

Event Description

This is 2 of 2 reports linked to mfg report number 3004608878-2023-00240: a facility reported that the mayfield modified skull clamp (a1059) was being used for cranial stabilization procedure, and a slip occurred.No patient injury or surgical delay has been reported.

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

N/a.

Manufacturer Narrative

Updated fields: d1, d4 (catalog# updated, udi#), d9, g3, g6, h2, h3, h6, h10 additional information: - the account manager clarified that it was the adaptor that had failed.- how long was the surgery delay? >> no delay- situation critical and anesthetist managed to support patient head.Event happened during surgery.- which side did the slip occur on and describe patient position? >> patient supine, mayfield head rest slipped/ dropped.- please describe the laceration if there was any? >> no laceration-near miss.- what was the intervention? >> reported and to be taken out of circulation.Clinical engineering notified and integra.New parts ordered and mayfield systems changed.- patient outcome? >> near miss- patient observed post operatively.Investigation findings: the mayfield swivel horseshoe headrest (a1012) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.As a result, 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.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: MAYFIELD SWIVEL HORSESHOE HEADREST
• Type of Device: N/A
• 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: 18428696
• MDR Text Key: 332606508
• Report Number: 3004608878-2023-00241
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 03/01/2024
• 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