MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; N/A

Catalog Number A1059

Device Problem Device Slipped (1584)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/09/2023

Event Type  Injury  

Manufacturer Narrative

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 - investigation of the returned unit was unable to duplicate "slippage." the unit does have slight movement in the lock, but when properly positioned and put under pressure, it did not move.Further, the unit was sent to quality engineering for further investigation, and the findings of the service & repair team were confirmed.Quality engineering noted no additional device deficiencies.Unrelated to the reported complaint, new components were added to replace all worn internal parts, and general maintenance and cleaning were performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Probable root cause of the complaint incident in improper or suboptimal placement of the skull clamp.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 Description

A facility reported that during a posterior cervical fusion case, the mayfield modified skull clamp (a1059) slipped, resulting in a 30-minute delay and an unspecified patient injury.Additional information has been requested.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: N/A
• 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: 18062400
• MDR Text Key: 327247829
• Report Number: 3004608878-2023-00197
• 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: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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