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	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mayfield swivel horseshoe headrest (a1012) was returned for evaluation: failure analysis - investigation of the returned unit was unable to duplicate slippage.However, the slide bar was re-pinned due to being loose, the washer and retaining ring were replaced due to being worn, and the large starburst was machined to add a helicoil.Additionally, all worn components were replaced with new parts, and general maintenance and cleaning were performed.Root cause - probable root cause is routine use and wear.The starburst teeth showed some wear but still passed all functional testing.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 mayfield swivel horseshoe headrest (a1012) was ¿slipping¿.No patient injury or surgical delay has been reported.

• 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
• 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: 17705223
• Report Number: 3004608878-2023-00163
• Device Sequence Number: 6632864
• 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
• Report Date (Section B): 09/07/2023

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: A1012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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