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

Catalog Number A1114

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  Injury  

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

A facility reported that the patients head slipped out of the mayfield infinity skull clamp (a114) during an unspecified surgery.It is unknown if the patient was injured and it is also unknown if there was delay or increased surgery time.

Manufacturer Narrative

The mayfield infinity skull clamp (a114) was returned for evaluation: device history record (dhr) - the dhr was reviewed and no anomalies related to the reported failure was observed.Failure analysis - evaluation was unable to conclusively verify customer information as valid.No defects detectable.The received skull clamp passes all functional tests.Root cause - the evaluation of the device could not duplicate the reported complaint.Device passed all specific functional testing requirements and slippage could not be duplicated.The definite root cause cannot be reliably determined but the most probably root cause is improper usage, and/or placement.No further investigation required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.

Manufacturer Narrative

Additional information received indicates the following : correct date of event : (b)(6) 2021.The patient was injured.One surgeon held the head of patient in his hands during suturing; the event occurred during wound closure, and the event led to increased surgery time for 10-15 minutes.

• Brand Name: MAYFIELD INFINITY 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: 12733823
• MDR Text Key: 279596839
• Report Number: 3004608878-2021-00617
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K051440
• 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,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1114
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/01/2021
• Supplement Dates Manufacturer Received: 11/19/2021; 12/29/2021
• Supplement Dates FDA Received: 11/24/2021; 01/11/2022
• 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