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

Catalog Number A1059

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A facility reported that the mayfield modified skull clamp (a1059) became unlocked while in use.No information has been provided on patient consequence or surgery delay.Additional information has been requested.

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

N/a.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomalies related to the reported failure was observed.Failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.No maintenance is currently required.Unrelated to the complaint issue, the swivel lock was found to have movement in the assembly and a residue buildup was present.Additionally, the unit required cleaning and replacement of worn parts from routine use and wear.Some worn off internal were replaced, general maintenance and cleaning were performed and the unit has been subjected to a successful functional check.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.The probable root cause of the reported complaint 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.

• 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: 17364085
• MDR Text Key: 319762767
• Report Number: 3004608878-2023-00131
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2023
• 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