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

Model Number A1059

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - evaluation of the returned unit showed that it passed all specific functional testing requirements, except for the lock having rotational movement when the unit is not under pressure.This would not have caused a slippage.When the unit is properly positioned and put under pressure it would not have slipped.Evaluation found no device deficiencies that would have contributed to "slippage." however, all worn components were replaced with new parts and general maintenance and cleaning performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Repairs team could not duplicate slippage.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

A facility reported patient was undergoing a partial resection of the arch of c1 for clipping of left posterior inferior cerebellar artery aneurysm, and that the mayfield modified skull clamp (a1059) slipped and caused laceration to the head.The skull clamp appeared to be fine, but it was suggested it be sent in for repair.No surgical delay has been reported.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: 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: 13012964
• MDR Text Key: 285036409
• Report Number: 3004608878-2021-00687
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2021

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
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1