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

Catalog Number A1059

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that there is movement when the mayfield modified skull clamp (a1059) is clamped and locked.The device was not in contact with a patient, therefore, no patient harm occurred.There was a delay of 10 minutes, however, no patient injury occurred.

Manufacturer Narrative

A duplicate report was submitted for this complaint event under mfg report number 3004608878-2023-00122.Consequently, no investigation results will be submitted for this event, as all information was previously submitted under mfg report number 3004608878-2023-00122 which is the active completed record in our database.At present, we consider this complaint to be closed.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Mayfield modified skull clamp (a1059) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed and found no anomalies.Based on the reported complaint, probable root cause is routine use and wear of the unit.Additionally, improper or suboptimal placement of the skull clamp on the patient can lead to slippage of the clamp or movement of the patient's head.Trends will be monitored for this and similar issues.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: 17191128
• MDR Text Key: 317757854
• Report Number: 3004608878-2023-00115
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2023

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?: Yes
• 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: 05/31/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 08/01/2023; 08/31/2023
• Supplement Dates FDA Received: 08/11/2023; 09/08/2023
• 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