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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 2 reports linked to mfg report number 3004608878-2023-00027: a facility reported that during "posterior fossa decompression +/- cervical laminectomy + resection of lesion" procedure, the mayfield composite series base unit (a3101) was used for cranial stabilization and experienced a slippage.The surgery was stopped, and patient was prepared again which delayed the procedure for 35 minutes.The procedure was successfully completed.Further details of the event were provided as follows: patient was put into the head clamp with pins before flipping them prone onto a prone bone foam.After patient was secured into position with arms tucked and patient connected to the base of mayfield setup.They proceeded with using the medtronic stealth machine and arm to correctly position the point of access to the lesion.Once they had finished final checks, they proceeded to prep the patient and drape.Once the final drape was placed onto patient, they noticed the patient had moved enough for them to stop the procedure before continuing.They removed the drapes and took the head clamp off while the patient was still prone.The surgeons proceeded to pin the patient into a new head clamp that was in working order.This initially caused delays to the theatre as they had to re-prep and drape the patient.
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.
Additional Manufacturer Narrative
Mayfield composite series base unit (a3101) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned unit showed that the reported fault was not replicated.There was a minor wear on the starburst of the swivel adaptor, but no slippage was observed.Repairs has been completed and the unit now meets manufacturer¿s specifications.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.There was minor wear to the swivel adaptor, but service & repair could not duplicate slippage.Probable root cause is improper or suboptimal placement of the mayfield system.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
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
• 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: 16391474
• Report Number: 3004608878-2023-00028
• Device Sequence Number: 12166934
• 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): 03/17/2023

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: A3101
• Device Catalogue Number: ¿A3101¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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: A1059 MAYFIELD MODIFIED SKULL CLAMP.; MEDTRONIC STEALTH MACHINE.
• Patient Age: 35 YR
• Patient Sex: Male