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 Laceration(s) (1946)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is 1 of 2 reports linked to mfg report number 3004608878-2023-00212: a facility reported that during revision posterior fossa decompression procedure, the mayfield modified skull clamp (a1059) which was used for cranial stabilization slipped on the patient's right side where the 2 pins were positioned.This led to a full-thickness laceration of approximately 5cm next to the vp shunt, requiring cleaning and suturing.As a result, the surgery was cancelled.No further details regarding craniofacial issues has been provided.Further information provided indicates that the hospital does its own mayfield inspection once per year, and integra's account manager has advised he has discussed retraining.However, the devices are being returned to integra service to be evaluated.

Event Description

N/a.

Manufacturer Narrative

  the mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis - investigation of the returned unit showed that there was no slippage n the locked condition.However, the index knob was soft to lock and unlock., and the threads had significant wear.Due to the age and condition of this unit, it cannot be returned to manufacturer¿s specifications (beyond integra¿s 7 years recommended life cycle).It was recommended that the unit be discarded and replaced.Therefore, this unit has been disposed locally.Root cause - the complaint is not confirmed as evaluation found no device deficiencies that would have contributed to the reported complaint.Probable root cause is improper or suboptimal placement of the skull clamp on the patient.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.

• 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: 18194238
• MDR Text Key: 328824577
• Report Number: 3004608878-2023-00211
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/15/2023
• 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
• Treatment: A3101 MAYFIELD COMPOSITE SERIES BASE UNIT
• Patient Age: 12 YR
• Patient Sex: Male