MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA STANDARD INFINITY SKULL CLAMP; N/A

Catalog Number	A1114A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mayfield infinity skull clamp (a1114) was returned for evaluation: failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.The clamp does have slight rotational movement in the lock, but that would not cause any movement once the clamp is properly positioned and put under pressure.However, the unit is older than 10 years old (manufactured in 2012) and is no longer serviceable and will be returned to the customer unrepaired due to its age.Root cause - the complaint is not confirmed.Probable root cause of the reported complaint 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 identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
A facility has reported that during an unspecified procedure, the patient's head moved in the mayfield infinity skull clamp (a1114).There was no patient injury and no known delay in surgery.
Additional Manufacturer Narrative
This supplemental mdr is for a correction to the catalog# submitted in the initial mdr.
Event or Problem Description
N/a.

• Brand Name: STANDARD INFINITY SKULL CLAMP
• Common Device Name: N/A
• 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: 18819516
• Report Number: 3004608878-2024-00026
• Device Sequence Number: 20900751
• Product Code: HBL
• UDI-Device Identifier: 10381780253556
• UDI-Public: 10381780253556
• Combination Product (Y/N): N
• PMA/510(K) Number: K051440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A1114A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown