MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD TRIAD SKULL CLAMP

Catalog Number A1108

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 mayfield skull clamp (a1108) pin came loose during an unspecified procedure.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.

Manufacturer Narrative

Dhr review: the dhr shows no abnormalities related to the reported failure.Mayfield triad skull clamp (a1108) was returned for evaluation.The evaluation and functional testing of the device could not duplicate the reported condition.Unit needs to be machined to have heli-coils added to large starburst threads; the lock had some residue build up and set screw in the swivel base was tight.The unit needs replacement of worn parts.General maintenance and cleaning required at this time.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 TRIAD SKULL CLAMP
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 11195484
• MDR Text Key: 228174967
• Report Number: 3004608878-2021-00017
• Device Sequence Number: 1
• Product Code: HBL
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1108
• Device Lot Number: 174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1