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

Catalog Number	A1114
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received indicating the following: 1.When placing the skull clamp, if you were to draw an imaginary line between the single pin and the rocker arm swivel point, did that imaginary line pass through an axial center of the skull? yes.2.Did each pin engage the cranium in a perpendicular approach? yes.3.Was there a delay in surgery due to product problem? yes, 30 min.4.Was there any patient adverse consequence because of the delay? no.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The mayfield infinity skull clamp (a1114) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The definite root cause cannot be identified as the device was not returned.However, a probable root cause for the reported complaint is improper or suboptimal placement of the skull clamp on the patient.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
A facility reported that during patient initial positioning for a "posterior cervical" case slippage occurred while patient was prone.The patient had to be flipped into supine position and scalp laceration was repaired with sutures.Patient was able to be re-pinned and surgery was completed.No information on surgical delay was provided.
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.

• Brand Name: MAYFIELD INFINITY SKULL CLAMP
• 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: 18819520
• Report Number: 3004608878-2024-00028
• Device Sequence Number: 18210617
• Product Code: HBL
• UDI-Device Identifier: 10381780253549
• UDI-Public: 10381780253549
• Combination Product (Y/N): N
• PMA/510(K) Number: K051440
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A1114
• Device Lot Number: 221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 03/07/2024; Not provided
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/22/2024; 04/18/2024
• Date Device Manufactured: 03/23/2022
• 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