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

Catalog Number	A1051
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
This is 1 of 2 reports linked to mfg report number 3004608878-2023-00241: 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.
Additional Manufacturer Narrative
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 pediatric horseshoe headrest (a1051) 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 PEDIATRIC HORSESHOE HEADREST
• Common Device Name: 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: 18428697
• Report Number: 3004608878-2023-00240
• Device Sequence Number: 18075382
• Product Code: HBL
• UDI-Device Identifier: 10381780267553
• UDI-Public: 10381780267553
• Combination Product (Y/N): N
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: A1051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 03/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown