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 03/18/2024

Event Type  Injury  

Event Description

This is 2 of 2 reports, and linked to mfg report number 3004608878-2024-00050: a facility reported that the mayfield modified skull clamp (a1059) unscrewed during procedure leading to removal of pins, and the patient's head was no longer maintained.The pins & skull clamp had to be re-positioned, and the nurse had to maintain the head of the patient to finalize the procedure.The child had bleeding which needed stitches.There was an increase of surgery time of 15 minutes.

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 skull clamp (a1059) was returned for evaluation: failure analysis - the investigation of the returned unit showed it had rotational and lateral movement in the swivel lock assembly and excessive dirt buildup.However, these issues are unlikely to contribute to patient movement.Unrelated to the reported issue, the skull clamp's base has worn off inner threads in the center of the starburst teeth, and the base must be machined and tabbed to insert helicoil threads.To resolve these issues, the base casting of the skull clamp was machined, heli-coil threads were inserted, the internal parts were replaced to adjust the unit according to the manufacturer specifications and to clean the skull clamp's swivel lock assembly.After completing the reassembly, including the adjustment, the skull clamp was subjected to a successful function test.Root cause - the complaint is not confirmed.The unit required replacement of worn parts from routine wear.Probable root cause of the loss in patient fixation is improper or suboptimal positioning of the skull clamp.No further investigation is 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.

• 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 08540 ; 6099362319
• MDR Report Key: 19089662
• MDR Text Key: 339941437
• Report Number: 3004608878-2024-00051
• 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: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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 Catalogue Number: A1059
• Device Lot Number: CB267565L_02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/23/2024
• 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
• Treatment: A2101 MAYFIELD ULTRA BASE UNIT
• Patient Age: 24 MO
• Patient Sex: Male