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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2021

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 during a c4-t2 posterior cervical fusion procedure, the anesthesiologist noticed that the patient's head came out of the pins.There were no signs of skin laceration from the pins, no bleeding.There was roughly a 10 minute delay to re-pin the patient with another mayfield skull clamp.The surgeon broke scrub and re-pinned while anesthesia stabilized the patient's head.The surgeon used the same pin site; integra a1072 disposable skull pins were used.No patient injury occurred.

Manufacturer Narrative

The mayfield infinity skull clamp (a1114) was returned for evaluation.Device history record (dhr): the dhr was received and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the unit was unable to confirm the complaint as valid.The returned unit passed all specific functional testing requirements.When pins and unit are properly positioned and put under pressure; the pins would not have came out.All worn components were added to replace worn parts.Root cause analysis: the evaluation of the device could not duplicate the reported complaint.When unit is properly positioned and put under pressure unit would not have slipped.When pins and unit are properly positioned and put under pressure; the pins would not have came out.The unit required repair and preventive maintenance.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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
• MDR Report Key: 12529440
• MDR Text Key: 273328101
• Report Number: 3004608878-2021-00570
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: A1072 MAYFIELD DISPOSABLE SKULL PINS