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

Catalog Number A1108

Device Problem Unintended Movement (3026)

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

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.Linked to mfg report number 3004608878-2020-00642.

Event Description

This is 1 of 2 reports.It was reported that the c-clamp has play or movement when locked.There was no known patient injury, or surgery delay.

Manufacturer Narrative

Unique device identification (udi): (b)(4).Device history record (dhr) - the dhr shows no abnormalities related to the reported failure.The reported complaint was confirmed from the visual evaluation of the returned product.The lock having both rotational and lateral movement; general maintenance and cleaning required.The observed condition is likely caused by wear and tear.The definite root cause cannot be reliably determined.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
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10744836
• MDR Text Key: 213901112
• Report Number: 3004608878-2020-00641
• 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: 10/06/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: A1108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1