MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD HORSESHOE HEADREST; N/A

Model Number	A1011
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that the surgeon stated that he does not like the metal knobs/design that are used to tighten the mayfield horseshoe headrest (a1011), because it is too difficult to tighten once the patient¿s head is on the headrest.Additional information received indicates that during a "posterior cervical decompression" procedure, the metal knobs were too difficult to tighten once the patient¿s head was on the headrest.As a result, there was a 30-minute delay in surgery with no patient injury reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The mayfield horseshoe headrest (a1011) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of this particular complaint relates to customer preference of knob design, rather than failure of product due to defect.There are no manufacturing issues to report, no dysfunction or breakage; thus, no further investigation is required.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.

• Brand Name: MAYFIELD HORSESHOE HEADREST
• Common Device Name: N/A
• 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: 16876978
• Report Number: 3004608878-2023-00082
• Device Sequence Number: 20266351
• Product Code: HBM
• UDI-Device Identifier: 10381780267430
• UDI-Public: 10381780267430
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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 Model Number: A1011
• Device Catalogue Number: A1011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 05/18/2023
• Date Device Manufactured: 04/27/2022
• 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