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

Catalog Number A1059

Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the pressure screw of the a1059 mayfield modified skull clamp was loose when tightened and there was a small amount of wobble factor to the rocker arm when locked.There was no patient injury and no known delay in surgery.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d10, g4, g7, h2, h3, h4, h6, h10.Unique device identifier (udi): (b)(4).The mayfield skull clamp was returned for evaluation: device history record (dhr) - review showed no abnormalities related to the reported failure.The reported complaint was confirmed from the evaluation.The threads in the large starburst are worn and need heli coils added.The observed condition is likely caused by wear and tear / improperly handling of the device.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 MODIFIED 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: 10497804
• MDR Text Key: 206110909
• Report Number: 3004608878-2020-00509
• 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: 08/11/2020

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: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1