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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the mayfield swivel horseshoe headrest (a1012) failed during use.The pin holding the square shaft in place fell out or broke and fell out, and this allowed the side of the horseshoe connected to the square shaft to shift.The patient was supine with head on the horseshoe during the procedure, after incision when the failure occurred.No patient injury and surgical delay has been reported.
Additional Manufacturer Narrative
The mayfield swivel horseshoe headrest (a1012) was returned for evaluation.Device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the inspection showed that the returned unit was received without roll pins allowing the slide bar to rotate freely.Additionally, the unit was sent to quality engineering (qe) for further investigation and the findings of the service team were confirmed by qe.The unit was in worn condition, and the slide bar was missing both roll pins and able to rotate freely when it should be fixed in place.No additional device deficiencies were observed by qe.To resolve the issues, all worn components will be replaced with new parts, and general maintenance and cleaning will be performed.Root cause - the complaint is confirmed via the investigation.The unit was received without roll pins allowing the slide bar to rotate freely.The probable root cause is rough or improper handling of the unit.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
Updated fields: additional information received as follows: 1.Can you please confirm the type of procedure the device was used? answer: spinal fusion surgery.2.Was there a delay in surgery due to product problem? if yes, how long (in minutes)? answer: the only delay was to retrieve another horseshoe from the supply room, less than 4 minutes.3.How was the patient initially positioned for the surgery? answer: supine.4.Was the patient repositioned at any time during the surgery? if yes, explain how the patient¿s position had changed after initial positioning had been completed? answer: no, the patient was not repositioned before the incident occurred.It occurred as the patient was transferred onto the or table, before final positioning and draping.
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: 22680264
• Report Number: 3004608878-2025-00155
• Device Sequence Number: 9447858
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: A1012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• 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