MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD

Catalog Number	A3101
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
This report is 2 of 3 and is linked to mfg report numbers 3004608878-2025-00046 and 3004608878-2025-00048: a facility reported that during a chiari repair case, the mayfield composite series base unit (a3101) slipped on the patient's skull despite all three pins appearing fully locked in place.Lacerations occurred on both sides of patient's skull and required stapling.The mayfield set up was removed and replaced with an alternative kit, and the surgeon proceeded with the operation.There was surgical delay of approximately 20 minutes.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h11.The mayfield composite series base unit, standard (a3101) was not returned after three good faith effort (gfes) attempts were made.Product serial number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.As a result, the root cause of the reported issue could not be determined.However, based on the reported complaint, the probable root cause 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
N/a.

• Brand Name: MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD
• Common Device Name: COMPOSITE SERIES
• 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: 21598665
• Report Number: 3004608878-2025-00047
• Device Sequence Number: 8349978
• Product Code: FWZ
• UDI-Device Identifier: 10381780268161
• UDI-Public: 10381780268161
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A3101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: A3018 MAYFIELD SWIVEL ADAPTOR; A3059 MAYFIELD SKULL CLAMP
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown