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

Catalog Number	A1114
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A facility reported that they had a patient slip with a mayfield skull clamp (catalog# unknown).Additional information has been requested.
Additional Manufacturer Narrative
The mayfield infinity skull clamp (a1114) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned unit showed that the lock has rotational and lateral movement and a residue buildup is present.All worn components were replaced with new parts, and general cleaning and maintenance were performed.Root cause - the complaint is confirmed via inspection of the unit.The lock was sticking and the unit required replacement of worn parts due to routine use and wear.However, it is unlikely this would contribute to a slippage, probable root cause of a patient slippage is improper or suboptimal placement of the skull clamp.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.
Additional Manufacturer Narrative
Additional information received: nature of the event: patient head slip out of original position.For what type of procedure was product or device used? posterior spinal fusion t2-s1.Did product malfunction? mayfield clamp was secured by attending physician to appropriate torque and on appropriate landmarks.Possible pressure loss as patient found slipped from original pin site.Did malfunction result in patient or user injury? yes.Patient laceration to scalp requiring suture.Did it result in death? no.
Event or Problem Description
N/a.

• Brand Name: MAYFIELD INFINITY SKULL CLAMP
• Common Device Name: 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: 18871648
• Report Number: 3004608878-2024-00029
• Device Sequence Number: 12693040
• Product Code: HBL
• UDI-Device Identifier: 10381780253549
• UDI-Public: 10381780253549
• Combination Product (Y/N): N
• PMA/510(K) Number: PRE-AMEND
• 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,Followup
• Report Date (Section B): 04/26/2024

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: A1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 03/27/2024; 04/19/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/18/2024; 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2017
• 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