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 10/03/2023

Event Type  Injury  

Manufacturer Narrative

The mayfield 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 - the reported complaint was confirmed from the evaluation.The skull clamp had rotational movement in its swivel lock assembly and a residue buildup was present.For the adjustment some worn-off internal parts must be replaced.To resolve all issues, the internal parts were replaced, and the skull clamp was carefully repaired according to the manufacturer's instructions.The swivel base rotates smoothly and has no movement when the index knob was in the locked position; the swivel lock closes and opens properly, and the index knob had a positive rollover.The skull clamp was subjected to a successful function test.Root cause - complaint is confirmed via inspection of the unit.There was movement in the swivel lock assembly and the unit required replacement of worn internal parts.Probable root cause is routine use and wear of the unit.Additionally, improper or suboptimal positioning of the skull clamp on the patient can contribute to movement of the patient.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.

Event Description

A facility reported that the screw on the mayfield modified skull clamp (a1059) suddenly got loose with the patient's head in the clamp.The patient sustained laceration of 5 cm from one of the pins, and the wound / laceration was sutured.No information was provided on delay/increase of surgery time.

• 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: 18062470
• MDR Text Key: 327244360
• Report Number: 3004608878-2023-00198
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• 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: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• 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