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 Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mayfield pediatric horseshoe headrest (a1051) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned unit found that the two halves of the horseshoe headrest were able to be separated despite the torque screw being tightened down in the headrest extension.Further evaluation compared the returned unit to fully functional units/parts and found that the torque screw for the headrest extension had been de-burred too far, resulting in surface area on the flat end of the screw being smaller.This led to an insufficient hold on the slide bar allowing the headrest extension to move.Root cause - complaint confirmed via inspection of the unit.The torque screw for the headrest extension had been de-burred too much, resulting in surface area on the flat end of the screw being smaller.This led to an insufficient hold on the slide bar allowing the headrest extension to move.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.At present, we consider this complaint to be closed.
Event or Problem Description
A facility reported that the left and right sides of the mayfield pediatric horseshoe headrest (a1051), did not stay together even with screw tightened down as hard as possible.During a case, the headrest failed to stay locked, causing the baby's head to slip as the two sides separated.Fortunately, there was no injury, but there was a 5-minute delay as they replaced it with another unit that did not slide.

• 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: 18388858
• Report Number: 3004608878-2023-00237
• Device Sequence Number: 3967441
• Product Code: HBM
• UDI-Device Identifier: 10381780267553
• UDI-Public: 10381780267553
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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