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

Model Number	A3101
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 2 reports linked to mfg report number: 3004608878-2022-00276.A facility reported that the mayfield composite series base unit (a3101) was being used for cranial stabilization and slipped while patient was being turned to prone position prior to commencement of the case.The slippage caused significant lacerations to the patient's head (6-7 cm) which required sutures to close.There was a delay of 20 minutes due to product problem.
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
N/a.
Additional Manufacturer Narrative
The mayfield composite series base unit (a3101) 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 definite root cause cannot be identified as the device was not returned.However, based on the reported complaint, probable root cause is improper or suboptimal placement of the mayfield system 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.

• 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
• 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: 16040273
• Report Number: 3004608878-2022-00277
• Device Sequence Number: 4897002
• 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): 02/03/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: A3101
• Device Catalogue Number: ¿A3101¿
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/04/2023
• Date Device Manufactured: 05/30/2018
• 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