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

Catalog Number A1059

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the mayfield skull clamp (mayfield) moved during an unspecified procedure.The surgeon was using a drill to make the burr hole and the mayfield slipped, but no visible lacerations were observed.The procedure continued and the surgeon realized that he had made the navigation off.During closing, the mayfield slipped again, and no lacerations were observed when visually checked.However, it was apparent that the patient¿s head moved as she was not in the same position.The surgeon believes it was the locking mechanism on clamp f that caused the issue.There was no known delay in surgery.Additional information has been requested.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Device history record (dhr) - the dhr shows no abnormalities related to the reported failure.Mayfield skull clamp was received with the lock having rotational and lateral movement and a residue buildup was present.Unit needs new components added to replace worn internal parts.Complaint not confirmed via inspection of the unit.No issues observed that would contribute to slippage.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Manufacturer Narrative

Additional information provided indicates that both the mayfield swivel adaptor (a1018) and the mayfield ultra base unit ( a2101) were used concomitantly during the procedure.No failure of these two devices were alleged by the facility.However, both devices were returned for evaluation as a precautionary measure and evaluation found no device deficiencies that would have contributed to the reported complaint.At present, we consider this complaint event to be closed.

• 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 45227
• MDR Report Key: 10837518
• MDR Text Key: 216944604
• Report Number: 3004608878-2020-00672
• Device Sequence Number: 1
• Product Code: HBL
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1