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

Catalog Number A1059

Device Problem Unstable (1667)

Patient Problem Laceration(s) (1946)

Event Date 09/14/2023

Event Type  Injury  

Event Description

A facility reported that when putting the head of the patient in the mayfield modified skull clamp (a1059) in ventral decubitus, the clamp get loose twice resulting in laceration (wound) of 5 cm.The wound was treated first with staple and then sutured.They continue to use the same device to complete the surgery.There was surgical delay of 30 minutes (time to suture the laceration of 5 cm and to place the head in the mayfield again).

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis - the investigation of the returned device showed that the skull clamp had a sticking swivel lock, and opening the mechanism showed that the base casting¿s plain bearing surface had dents.The base casting was replaced along with the internal parts to adjust the swivel lock assembly.After completing the repair, a successful functional test was performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.The swivel lock was sticking and required replacement of worn internal parts; however, this would not have contributed to patient slippage.Probable root cause is improper or suboptimal placement of the skull clamp on the patient.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

N/a.

• 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: 17885757
• MDR Text Key: 325082702
• Report Number: 3004608878-2023-00187
• 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: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2023
• 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