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

Catalog Number	A1012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
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 4 reports linked to mfg report numbers: 3004608878-2024-00107 3004608878-2024-00108 3004608878-2024-00109.A facility reported that four incidences of pressure injury occurred after using the mayfield swivel horseshoe headrest (a1012) and the mayfield pediatric horseshoe headrest (a1051).It is unknown if there was a delay in surgery; however, additional information has been requested.Additionally, the facility has indicated there was no malfunction of the device and is performing a multifactorial root cause analysis.
Additional Manufacturer Narrative
Additional information has been received indicating the following: please verify the date of each incident: (b)(6) 2024.Was medical/surgical intervention required? if yes, what revision/intervention was performed during each incident? medical intervention post procedure included inpatient and outpatient wound therapy treatments.Was there a delay in surgery due to product problem? if yes, how long (in minutes)? no delay in surgery.How was the procedure completed for each incident? patient was positioned prone for surgery, incident noticed after procedure completed.Please provide patient outcome for each incident.Patient had bilateral pressure injuries to cheek areas noted after procedure finished.The patient had to receive inpatient and extensive outpatient wound therapy treatment.Please provide patient information: date of birth: (b)(6) 2024.Age: 3 months at time of surgery.Gender: male.Weight: 6.6kg.Ethnicity (hispanic/latino, not hispanic/latino): hispanic or latino.
Additional Manufacturer Narrative
The mayfield swivel horseshoe headrest (a1012) was not returned for evaluation because the hospital discarded the old mayfield horseshoe headrest a1012 when the new headrests were delivered to them.Additionally, the serial number provided is not valid for catalog# a1012; therefore, the device history record (dhr) could not be reviewed.The root cause of the reported issue cannot be determined.However, based on the reported complaint, probable root cause is improper or suboptimal use and positioning of the device.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.
Event or Problem Description
N/a.

• Brand Name: MAYFIELD SWIVEL 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 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20153886
• Report Number: 3004608878-2024-00106
• Device Sequence Number: 4235762
• Product Code: HBM
• UDI-Device Identifier: 10381780267461
• UDI-Public: 10381780267461
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A1012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 11/08/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/27/2024; 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 MO
• Patient Sex: Male
• Patient Weight: 7 KG
• Patient Ethnicity: Hispanic